Study ID | Intervention | Control | Adverse events in the intervention arm | Adverse events in the control arm | Comments |
Akizawa 2002 | L‐DOPS (400 or 200 mg) | Placebo | Overall, 5/100 patients in the treatment group reported headache, increased blood pressure, urinary retention, facial hot flushed, bad feeling, drug eruption, but number of patients who reported each adverse event was not reported | Feeling irritated (1), insomnia (1) | Quote: "Adverse events occurred in 3/51 patients in the 400 mg group (5.9%; i.e.,headache, increased blood pressure, urinary retention), 2/49 patients in the 200 mg group (4.1%; i.e., headache, increased blood pressure, facial hot flushed, bad feeling, drug eruption), and 1/49 patients in the placebo group (2.0%; i.e., feeling irritated, insomnia)." |
ASCEND 2016 | Sertraline | CBT | Death 0/60, hospitalisation/other 9/60, major bleeding 1/60, cardiac 3/60, gastrointestinal 1/60, infection 2/60, other 2/60 | Death 2/60, hospitalisation/other 14/60, major bleeding 2/60, cardiac 4/60, gastrointestinal 1/60, infection 2/60, other 8/60 | Quote: "Serious adverse events occurred in both treatment groups: 13 in 11 patients in the CBT group and 18 in 14 patients in the sertraline group. Nonserious adverse events were more frequent in the sertraline (56 events in 25 patients) than the CBT (17 events in 12 patients) group." |
ASSertID 2015 | Sertraline | Placebo | Adverse events and/or serious adverse events (9/15); cardiovascular death (1/15) | Adverse events and/or serious adverse events (9/15); cardiovascular death (0/15) | Quote: "Eighteen patients experienced adverse events (24) and/ or SAEs (13), nine in each randomized group. Infections (8) and nausea (4) were the most commonly reported adverse events. With regard to the SAEs, there was one death that was possibly related to the study medication as mentioned above, six SAEs that were unlikely to be related, and six SAEs that were not related to the study medication." "In the sertraline group, there were six dropouts within the first 2 months. One patient died of cardiac arrest having taken one tablet. Three patients withdrew because of adverse events (one after 3 days with nausea, another after 12 days with headaches and dizziness, and the third due to insomnia after 23 days). The fifth patient withdrew because of concern about side effects, having taken no study medication. The sixth patient was admitted for a prolonged hospital stay with leg ulcers shortly after randomisation and subsequently withdrawn without having taken any study medication. At 3 months, a seventh patient withdrew because of sweating and palpitations. In the placebo group, one patient withdrew after the baseline interview because of concern about taking additional medication, and a second decided against continuing after 3 months." |
BA16285 2007 | C.E.R.A. (once/week) | C.E.R.A. (once every 2 weeks) | Adverse events were reported for all study participants without distinction between groups (fatigue, anaemia, headache, vomiting, dizziness, diarrhoea, upper respiratory tract infection, nausea, dyspnoea, kidney transplantation, chest pain, muscle cramp or spasm, pyrexia, constipation, pruritus, rectal cancer, accelerated hypertension, cerebrovascular accident, death, acute myocardial infarction and multiple organ failure, chronic renal failure) | Adverse events were reported for all study participants without distinction between groups (fatigue, anaemia, headache, vomiting, dizziness, diarrhoea, upper respiratory tract infection, nausea, dyspnoea, kidney transplantation, chest pain, muscle cramp or spasm, pyrexia, constipation, pruritus, rectal cancer, accelerated hypertension, cerebrovascular accident, death, acute myocardial infarction and multiple organ failure, chronic renal failure) | Quote: "During the core study period, 4 AEs led to premature withdrawal (worsening anaemia [2 patients in group A and 1 in group C] and kidney transplant [1 in group A]). All cases of anaemia were considered to be related to study medication, whereas the kidney transplant was not. There were 5 withdrawals because of AEs in the extension period (pruritus, chest pain, rectal cancer, accelerated hypertension, and cerebrovascular accident [1 patient each]). In addition, dialysis was discontinued in 1 patient (at the request of her family), who was subsequently withdrawn from the study. The investigator classified this as an AE of chronic renal failure. All AEs leading to withdrawal in the extension period were considered to be unrelated to the study medication with the exception of accelerated hypertension (1 patient), which was classified as an SAE. Nineteen patients experienced an SAE during the core period, and 22, during the extension period. Two patients died during the extension period of the study (acute myocardial infarction and multiple organ failure); these deaths were deemed as SAEs. Neither death was considered related to treatment." |
Barre 1988 | Low dialysate sodium | High dialysate sodium | In general, adverse events were reported for all study participants without clear distinction between groups (fatigue, thirst, cramps, back pain, stomach‐ache, irritability, nausea, vomiting, headache, weakness, restlessness, itchiness, or any other symptoms) | In general, adverse events were reported for all study participants without clear distinction between groups (fatigue, thirst, cramps, back pain, stomach‐ache, irritability, nausea, vomiting, headache, weakness, restlessness, itchiness, or any other symptoms) | Quote: "One patients accounted for 52% of symptoms during dialysis and 58% of symptoms between dialyses. As noted, thirst was significantly less frequent with a sodium dialysate of 150 mEq/L, whereas headache was more frequent with the same dialysate. Fatigue during dialysis was more frequent with sodium dialysate of 145 mEq/L, whereas other symptoms, including cramps, back pain, stomachache, and irritability, were less frequent with a sodium dialysate of 155 mEq/L. Symptoms between dialyses, including thirst and headache, were more frequent with dialysate sodium of 155 mEq/L but were only present in two patients." |
Bicer 2022 | Acupressure | Placebo | 70.1% of the patients in the intervention group experienced hypotension | 0.9% of the patients in the placebo group experienced hypotension | Quote:" The procedure‐related side effects did not develop in all the patients included in the study and no patients felt unwell during or after the procedure." |
BOLD 2020 | Home SBP | Pre‐dialysis SBP | Post‐dialysis SBP<90 mmHg 2/25, post‐dialysis SBP>200 mmHg 3/25, syncope 1/25, fall 3/25, flash pulmonary oedema 0/25, cramping 13/25, dizziness 10/25, light‐headedness 14/25, hypotension 21/25. | Post‐dialysis SBP<90 mmHg 0/25, post‐dialysis SBP>200 mmHg 2/25, syncope 1/25, fall 6/25, flash pulmonary oedema 0/25, cramping 18/25, dizziness 14/25, light‐headedness 12/25, hypotension 18/25. | Quote: "The proportion of dialysis treatments with either excessively low or high pre or post dialysis SBP was small and similar in the two treatment groups. The rates of syncope, falls and flash pulmonary edema were also comparable between treatment groups." |
Brass 2001 | L‐carnitine | Placebo | In general, adverse events were reported for all study participants without clear distinction between groups (flu syndrome, injection‐site reaction, pain, pharyngitis, headache, hypertension). The intervention group reported serious adverse events (data included study A and B): body injection site reaction (4/130), infection (2/130), chest pain (3/130), abdominal pain (2/130), fever (1/130), accidental injury (1/130), neck pain (1/130), tachycardia (3/130), atrial fibrillation (1/130), hypertension (1/130), hypotension (1/130), aortic stenosis (1/130), colitis (1/130), vomiting (2/130), parathyroid disease (1/130), hyperkalaemia (2/130), hypervolaemia (1/130), lung oedema (1/130), pneumonia (1/130), skin carcinoma (1/130), amblyopia (1/130), urogenital kidney failure (8/130) |
In general, adverse events were reported for all study participants without clear distinction between groups (flu syndrome, injection‐site reaction, pain, pharyngitis, headache, hypertension). The control group reported serious adverse events (data included study A and B): body injection site reaction (6/63), infection (4/63), chest pain (0/63), abdominal pain (0/63), fever (0/63), accidental injury (0/63), neck pain (0/63), tachycardia (0/63), atrial fibrillation (0/63), hypertension (0/63), hypotension (0/63), aortic stenosis (0/63), colitis (0/63), vomiting (0/63), parathyroid disease (0/63), hyperkalaemia (0/63), hypervolaemia (0/63), lung oedema (0/63), pneumonia (0/63), skin carcinoma (0/63), amblyopia (0/63), urogenital kidney failure (3/63) |
Quote: "The most commonly reported adverse events were flu syndrome, injection‐site reaction, pain, pharyngitis, headache, and hypertension and showed no difference in frequency between L‐carnitine and placebo. Several serious adverse events occurred during the course of the study, with no differences between active and placebo groups. No serious adverse event was believed by the investigators to be certainly or probably drug related and they were consistent with the population's underlying disease and maintenance haemodialysis treatment." Table 7 reported "events that occurred only in placebo groups were not listed". |
Canadian EPO 1990 | EPO alfa | Placebo | Adverse events for both intervention groups were reported: seizure (2/78), clotting of vascular access (11/78), clotting of tubing in dialysis machine (8/78), pain in chest (13/78), epistaxis or haemorrhage (10/78), abnormal sense of taste (11/78), headache (26/78), redness of eyes (5/78), flu‐like symptoms (18/78), aches in bone or muscle (20/78). | Adverse events in the control group were reported: seizure (1/40), clotting of vascular access (1/40), clotting of tubing in dialysis machine (4/40), pain in chest (6/40), epistaxis or haemorrhage (7/40), abnormal sense of taste (6/40), headache (19/40), redness of eyes (0/40), flu‐like symptoms (12/40), aches in bone or muscle (9/40). | Table V reported in the Canadian EPO 1990. |
Chang 2010 | Exercise | Control | Adverse events were not reported in the intervention group | All adverse events were not reported in the control group. However, authors reported that a muscle/joint pain (1/35) led to early termination | Quote: "There were three early terminations due to a Borg score of 15 (1), muscle/joint pain (1), and unsteady pedal speed (1). All occurred among the sedentary subjects." |
Chen 2008a | CBT | Education | One participant with underlying stable major depression experienced a minor episode, but it was not reported in which treatment group he was allocated. 1/13 participants in the intervention group experienced morning dyspnoea |
One participant with underlying stable major depression experienced a minor episode, but it was not reported in which treatment group he was allocated. Other adverse events were not reported in the control group |
Quote: "One participant with underlying stable major depression experienced a minor episode because of cessation of antidepressant therapy. One participant in the CBT group experienced 1 episode of morning dyspnoea after a large meal during the last week of this 4‐week trial." |
Chen 2011a | CBT | Education | There were no adverse events in the intervention group | There were no adverse events in the control group | Quote: "No adverse events were reported during the intervention." |
Eroglu 2022 | Relaxation + music | Control | No information was reported in detail | No information was reported in detail | Quote: "Moreover, no participants dropped out owing to unexpected adverse effects of BRT combined with music therapy." |
Fatouros 2010 | L‐carnitine | Placebo | No adverse events were reported in the intervention group | No adverse events were reported in the control group | Quote: "No adverse clinical effect related to L‐carnitine supplementation was reported." |
FHN DAILY 2007 | Frequent HD | Conventional HD | Death 5/125, all hospitalisation 109/125, all interventions related to vascular access 95/125, hypokalaemia 13/125, hyperphosphataemia 15/125 | Death 9/120, all hospitalisation 114/120, all interventions related to vascular access 65/120, hypokalaemia 6/120, hyperphosphataemia 9/120 | Quote from FHN trial 2010: "Adverse events were reported in table 4." |
Foley 2000 | EPO alpha (Hb target 9.5‐10.6 g/dL) | EPO alpha (Hb target 13‐14 g/dL) | Arteriovenous access thrombosis and cardiac events were reported in the low target Hb group but the number of patients was not reported. During the study period 3/73 participants died in the low target Hb group | Arteriovenous access thrombosis and cardiac events were reported in the high target Hb group but the number of patients was not reported. During the study period 4/73 participants died in the high target Hb group | Quote: "The comparative incidence of arteriovenous access thrombosis, cardiac events, and death." |
Fukuda 2015 | Nutritional supplementation | Placebo | Adverse events in the intervention group were reported: increased blood pressure (1/103), dizziness (1/103), insomnia (1/103), nausea (1/103), diarrhoea (2/103), sudden hearing loss (1/103). One participant in each group had cramp in the lower leg | Adverse events in the control group were reported: increased glucose level (1/99), felt sick (2/99), stomach discomfort (1/99), hospitalisation (2/99). One participant in each group had cramp in the lower leg |
Quote: "In the nutritional drink group, one participant reported increased blood pressure, one complained of dizziness, one complained of insomnia, one reported nausea, and two had diarrhoea. One participant in each group had cramp in the lower leg. In the placebo group, one participant reported increased glucose level, two felt sick, and one complained of stomach discomfort. One participant developed sudden hearing loss and was prescribed any vitamins. Two participants were hospitalised in the placebo group. The safety monitoring board confirmed no serious adverse events, and hospitalisation was determined relating to the study intervention." |
Grigoriou 2021 | Exercise | Control | Not reported in sufficient detail | Not reported in sufficient detail | Quote: "All participants completed both scenarios without any adverse effects or significant complaints." |
HDPAL 2014 | Atenolol | Lisinopril | A questionnaire assessed the following adverse events: fatigue or tiredness, chest pain, abdominal pain, cold hands or feet, dizziness on standing, muscle cramps, diarrhoea, nausea, vomiting, dry cough, upper respiratory infection or common cold, shortness of breath, headaches, persistent dizziness, numbness in hands or feet, decreased sex drive, decreased ability to have sex, drowsiness or sleepiness, depression or feeling sad and nightmares. However, data were not reported considering the treatment assigned (for only 133 patients who completed the questionnaire). Adverse events in the intervention group were reported: overall serious adverse events (58/100), all‐cause hospitalisation (37/100), infections (24/100), access‐related (17/100), central nervous system (3/100), cancer‐related complications (2/100), cardiovascular event (16/100), angina (0/100), arrhythmia (2/100), cardiac arrest (0/100), congestive heart failure (5/100), myocardial infarction (2/100), peripheral vascular disease (1/100), revascularization (3/100), stroke (2/100), valve replacement surgery (1/100), cardiovascular death (2/100), non‐cardiovascular death (2/100), fractures (7/100), parathyroidectomy (3/100), biliary‐related (1/100), bowel‐related (3/100), falls (6/100), gastrointestinal bleeding (2/100), hypertensive crisis (3/100), hyperglycaemia (1/100), hyperkalaemia (3/100), hypoglycaemia (2/100), hypotension with hospitalisation (6/100), miscellaneous (12/100) |
A questionnaire assessed the following adverse events: fatigue or tiredness, chest pain, abdominal pain, cold hands or feet, dizziness on standing, muscle cramps, diarrhoea, nausea, vomiting, dry cough, upper respiratory infection or common cold, shortness of breath, headaches, persistent dizziness, numbness in hands or feet, decreased sex drive, decreased ability to have sex, drowsiness or sleepiness, depression or feeling sad and nightmares. However, data were not reported considering the treatment assigned (for only 133 patients who completed the questionnaire). Adverse events in the control group were reported: overall serious adverse events (70/100), all‐cause hospitalisation (59/100), infections (20/100), access‐related (19/100), central nervous system (3/100), cancer‐related complications (2/100), cardiovascular event (28/100), angina (2/100), arrhythmia (3/100), cardiac arrest (2/100), congestive heart failure (10/100), myocardial infarction (3/100), peripheral vascular disease (5/100), revascularization (4/100), stroke (2/100), valve replacement surgery (1/100), cardiovascular death (3/100), non‐cardiovascular death (1/100), fractures (1/100), parathyroidectomy (1/100), biliary‐related (2/100), bowel‐related (5/100), falls (3/100), gastrointestinal bleeding (5/100), hypertensive crisis (10/100), hyperglycaemia (3/100), hyperkalaemia (10/100), hypoglycaemia (4/100), hypotension with hospitalisation (5/100), miscellaneous (18/100) |
Quote from Agarwal 2016: "The symptoms were as follows: fatigue or tiredness, chest pain, abdominal pain, cold hands or feet, dizziness on standing, muscle cramps, diarrhoea, nausea, vomiting, dry cough, upper respiratory infection or common cold, shortness of breath, headaches, persistent dizziness, numbness in hands or feet, decreased sex drive, decreased ability to have sex, drowsiness or sleepiness, depression or feeling sad and nightmares." Quote from Agarwal 2014;"Table 3 shows the serious adverse events between groups over the course of the trial." |
Johansen 1999 | Nandrolone decanoate | Placebo | Adverse events in the intervention group were reported: hematoma (1/14), reduction in testicular size (1/14), amenorrhoea (1/14), acne (1/14), hypertension (3/14) | Adverse events in the control group were reported: hematoma (1/15), skin rash (2/15), hypertension (3/15) | Quote:"Reason for inability to undergo treadmill included coronary artery disease (7 subjects), severe hypertension (2 subjects), hospitalisation (3 subjects), study drop‐out (2 subjects), valvular heart disease, amputation, arthritis, abdominal hernia, and diabetic foot ulcer (1 subject). [...] The study was generally well tolerated, but minor adverse events occurred. Two subject (one in each arm) developed hematoma. One nandrolone recipient complained of a reduction in testicular size that resolved with dose reduction.two men (both in the placebo group) complained of skin rash. Of the 3 women who received nandrolone, 2 required dose reduction for amenorrhoea and acne, respectively. [...] Six subjects (3 in each group) required increase in antihypertensive medication dosages." |
Johansen 2006 | Nandrolone decanoate with or without exercise | Placebo with or without exercise | Adverse events in both intervention groups were reported: interference with sexual function (1/39) | Adverse events in the both control groups were reported: death (1/40), not feeling well (1/40), abdominal pain (1/40), itchy reaction (1/40) | Quote: "Those who received placebo discontinued because of an itchy reaction at the injection site, a nonspecific feeling that the drug was having adverse effects, abdominal pain and liver function test abnormalities, and discovery of a history of prostate cancer. Those who received nandrolone discontinued because of interference with sexual function (after five doses) and fear of possible adverse effects (after three doses)." |
Konstadinidou‐ND 2002 | Exercise | Control | Adverse events in both intervention groups were reported: death (1/36) | Adverse events in the control group were reported: death (1/12) | Quote:"However, during the study 5 patients from Group A, 1 from Group B, 2 from C voluntarily withdrew, while 1 patient from Group B and 1 from D died of causes unrelated to exercise." |
Krase 2022 | Exercise | Control | No detailed information was reported | No detailed information was reported | Quote: "Exercise was well tolerated by all patients, and no adverse reactions were reported." |
Leski 1979 | Dialysate containing glucose | Dialysate without glucose | The study assessed fatigue, headache and leg cramps using a questionnaire: number of patients who reported these adverse events after dialysis was not reported. Hypotension was recorded but the author did not report information neither on the intervention group allocation nor on the number of cases | The study assessed fatigue, headache and leg cramps using a questionnaire: number of patients who reported these adverse events after dialysis was not reported. Hypotension was recorded but the author did not report information neither on the intervention group allocation nor on the number of cases | Quote: "Headache diminished in frequency during the sessions after the sessions. Fatigue during dialysis was not significantly altered, however post‐dialysis fatigue dropped significantly. The episodes of hypotension decreased in number, but not significantly. The same was the case for cramps." |
Li 2014b | Nurse led telephone support | Control | As reported in figure 1, death was reported in the intervention group but the number of patients was not reported. No data were clearly reported for oedema, peritonitis, catheter infections, exit‐site condition in the intervention group |
As reported in figure 1, death was reported in the control group but the number of patients was not reported. No data were clearly reported for oedema, peritonitis, catheter infections, exit‐site condition in the control group |
Quote: "The presence of edema, existence of peritonitis, catheter infections, exit‐site condition and weight gain were observed as the complication control of the participants within 42 days (6 weeks) and 84 days (12 weeks) post‐discharge." |
Lillevang 1990 | EPO | Placebo | Adverse events in the intervention group were reported: skeletal pain (1/9), abdominal pain (1/10) | Adverse events in the control group were reported: bodily distress (1/9), leg cramps (1/10) | Quote:"During the study period, the following adverse effects was registered (defined as new complaints from the patients, independent of the patients perception of relationship with the treatment): in the treatment group, there was one case of skeletal pain and one case of abdominal pain; in the placebo group, there was one case of “bodily distress” and one case of leg cramps." |
Linde 2001 | EPO alpha to achieve normal‐Hb target | Subnormal‐Hb target with or without ESA | Overall, in the intervention group there were the following adverse events: death (25/180), adverse events (29/180). Specifically:
5 participants had sepsis Data related to predialysis patient were not reported because they were out of our scope |
Overall, in the control group there were the following adverse events: death (26/164), adverse events (14/164). Specifically:
7 participants had sepsis Data related to predialysis patient were not reported because they were out of our scope |
Quote from Furuland 2003: "In a multivariate logistic regression analysis of SAE the number of patients with at least one SAE was 110 and 97 in the N‐Hb and S‐Hb groups, respectively. [...] Five patients in the N‐Hb group and seven in the S‐Hb group had sepsis." |
Mohammadpourhodki 2021 | Aromatherapy | Placebo | None known | None known | Quote: "None of patients included in the intervention groups reported side effects or local or general complications." |
Muz 2017 | Aromatherapy | Control | As reported in figure 1, participants in the intervention group reported: nausea and vomiting (1/41), increase of blood pressure (2/41). | No adverse events were reported for the control group in figure 1. | No relevant quotations were reported |
Parfrey 2005 | ESA (normal Hb target) | ESA (high Hb target) | Adverse events in the intervention group 1 were reported: any (281/300), hypertension (110/300), hypotension (105/300), platelet/bleeding/clotting arteriovenous fistula thrombosis (23/300), hematoma (36/300), arteriovenous fistula loss (26/300), vomiting (52/300), diarrhoea (53/300), nausea (53/300), abdominal pain (46/300), upper respiratory tract infection (69/300), dyspnoea (42/300), cough (36/300), pharyngitis (31/300), myalgia (85/300), skeletal pain (64/300), arthralgia (43/300), headache (64/300), dizziness (40/300), skin disorder (39/300), pruritus (33/300), infection (32/300), urinary tract infection (27/300), hyperparathyroidism (30/300), pain (47/300), back pain (40/300), fever (42/300), influenza (37/300), device complication (27/300), surgery (39/300), arteriovenous fistula thrombosis (36/300), non‐site‐specific embolism thrombosis (12/300), permanent catheter thrombosis (9/300), cerebrovascular disorder (4/300), peripheral ischaemia (7/300), angina pectoris (8/300), myocardial infarction (4/300), chest pain (7/300), permanent catheter loss (6/300), arteriovenous fistula loss (27/300), arteriovenous graft loss (9/300), tachycardia (15/300), palpitations (9/300), atrial fibrillation (7/300), bradycardia (5/300), pulmonary oedema (16/300), cardiac failure (6/300), pulmonary oedema or heart failure (19/300), death (20/300) | Adverse events in the intervention group 2 were reported: any (284/296), hypertension (120/296), hypotension (85/296), platelet/bleeding/clotting arteriovenous fistula thrombosis (30/296), hematoma (45/296), arteriovenous fistula loss (30/296), vomiting (54/296), diarrhoea (50/296), nausea (47/296), abdominal pain (45/296), upper respiratory tract infection (72/296), dyspnoea (35/296), cough (35/296), pharyngitis (29/296), myalgia (81/296), skeletal pain (39/296), arthralgia (36/296), headache (86/296), dizziness (16/296), skin disorder (41/296), pruritus (23/296), infection (34/296), urinary tract infection (29/296), hyperparathyroidism (19/296), pain (41/296), back pain (35/296), fever (30/296), influenza (30/296), device complication (42/296), surgery (20/296), arteriovenous fistula thrombosis (45/296), non‐site‐specific embolism thrombosis (14/296), permanent catheter thrombosis (8/296), cerebrovascular disorder (12/296), peripheral ischaemia (8/296), angina pectoris (9/296), myocardial infarction (7/296), chest pain (4/296), permanent catheter loss (7/296), arteriovenous fistula loss (30/296), arteriovenous graft loss (9/296), tachycardia (22/296), palpitations (6/296), atrial fibrillation (6/296), bradycardia (7/296), pulmonary oedema (9/296), cardiac failure (2/296), pulmonary oedema or heart failure (11/296), death (13/296) | Quote from Parfrey 2005: "Treatment‐emergent adverse events that occurred in at least 10% of patients; vascular, access loss, and cardiac events that occurred in at least 2% of patients; and death in lower and higher target groups. " |
PEDAL 2020 | Exercise | Control | Greenwood 2021 reported: serious adverse events 69/175, blood and lymphatic system disorders 2/175, cardiac disorders 9/175, congenital disorders 0/175, gastrointestinal disorders 10/175, hepatobiliary disorders 2/175, infections and infestations 29/175, injury 15/175, metabolism and nutritional disorders 13/175, musculoskeletal and connective tissue disorders 3/175, cancer 1/175, nervous system disorders 5/175, psychiatric disorders 3/175, renal and urinary disorders 0/175, respiratory disorders 10/175, reproductive disorders 1/175, skin and subcutaneous tissue disorders 1/175, surgical procedures 24/175, vascular disorders 4/175 | Greenwood 2021 reported: serious adverse events 56/160, blood and lymphatic system disorders 0/160, cardiac disorders 6/160, congenital disorders 1/160, gastrointestinal disorders 4/160, hepatobiliary disorders 1/160, infections and infestations 18/160, injury 12/160, metabolism and nutritional disorders 4/160, musculoskeletal and connective tissue disorders 1/160, cancer 0/160, nervous system disorders 3/160, psychiatric disorders 1/160, renal and urinary disorders 1/160, respiratory disorders 3/160, reproductive disorders 1/160, skin and subcutaneous tissue disorders 0/160, surgical procedures 13/160, vascular disorders 6/160 | Quote from Greenwood 2021: "The number of patients with harms (serious adverse events) was similar in the intervention group (n = 69) and control group (n = 56)." |
Picariello 2018 | CBT | Control | Admission to hospital 1/18 | Admission to hospital 2/7 | Quote: "No trial adverse events occurred." |
Reilly‐Spong 2015 | Meditation | Control | There were no adverse events in the intervention group | There were no adverse events in the control group | Quote from Reilly‐Spong 2015: "No adverse effects related to the interventions were reported." |
Salehi 2020 | Exercise | Control | None known | None known | Quote: "None of the patients suffered from such complications and all participated without interruption." |
Sang 1997 | Steady dialysate sodium |
Linear sodium ramping Stepwise sodium ramping |
Adverse events (hypotension, cramps, fatigue, thirsty and total symptoms) were recorded as score in all treatment groups. Other adverse events were not clearly stated | Adverse events (fatigue, thirsty and total symptoms) were recorded as score in all treatment groups. Other adverse events were not clearly stated | Quote: "The number of symptomatic or asymptomatic hypotensive episodes and the time of occurrence of a hypotensive episode were recorded. [...] It was noted when the patient complained of angina, cramps, nausea, or headaches, or vomited. [...] Thirst, fatigue, dizziness and total symptoms were also recorded." |
Schardong 2021 | Laser | Control | Not reported in sufficient detail | Not reported in sufficient detail | Quote: "Regarding the safety of this therapy, no changes were observed in patients’ vital signs and adverse effects during laser applications, as well as in the interval between them." |
Schmitz 2016 | Citrate dialysate | Standard citrate | Adverse events (including death) were not clearly reported per group in the first phase on the study period | Adverse events (including death) were not clearly reported per group in the first phase on the study period | Quote: "The events such as cramps and hypotension were more frequent with citrate dialysate. [...] The most common adverse events during standard dialysate use were infections and vascular disorders. During the citrate dialysate phase, the most frequent events were general disorders like fatigue, followed by infections and musculoskeletal disorders, e.g. muscle spasm or pain." |
Semeniuk 2000 | Nutritional supplementation | Placebo | Not reported in sufficient detail | Not reported in sufficient detail | Some adverse events were reported (gastrointestinal and cardiovascular adverse events, hypotension). However, no data were clearly reported for the first phase of the cross‐over study. |
Singer 2010 | Vitamin C | Placebo | Adverse events in the intervention group were reported: acute coronary syndrome (0/37). Other adverse events (including commence dialysis, bacteraemia and dialysis access thrombosis) were not clearly stated |
Adverse events in the control group were reported: acute coronary syndrome (0/38). Other adverse events (including commence dialysis, bacteraemia and dialysis access thrombosis) were not clearly stated |
Quote: "During the study, there were no episodes of acute coronary syndrome, and two subjects commenced dialysis, both to the PD modality. There were too few bacteraemia (two in ascorbate group and one in placebo group) and dialysis access thromboses (one in ascorbate group) to analyse differences between the groups." |
Singh 2003 | Dialyser | Dialyser | Adverse events were not clearly reported per group in the first phase on the study period | Adverse events were not clearly reported per group in the first phase on the study period | Quote: "Among clinical symptoms nausea was the most common symptom, which occurred in 62% sessions on cuprophan, and 54% on polysulfone membrane, the difference was not significant. Vomiting, chest pain, fever, chills, and breathlessness occurred significantly more during dialysis with cuprophan membrane as compared with polysulfone. Cramps, back pain, itching, restlessness, post dialysis fatigue, and hypotension did not significantly differ." |
Singh 2008a | Iron replacement product | Placebo | Adverse events (including death) were not clearly reported per group in the first phase on the study period | Adverse events (including death) were not clearly reported per group in the first phase on the study period | No relevant quotations were reported. |
Sklar 1999 | Dialysis procedures | Sham dialysis procedures | Adverse events (including death) were not clearly reported per group in the first phase on the study period | Adverse events (including death) were not clearly reported per group in the first phase on the study period | No relevant quotations were reported. |
Suzuki 2018 | Exercise | Control | Cramps 1/13, muscle pain 3/13 | Cramps 0/13, muscle pain 0/13 | Quote: "In the EMS group, leg cramps occurred in one patient during EMS but rapidly faded without treatment. Muscle pain was reported by three patients after EMS but spontaneously healed within a few days." |
Thomas 2017 | Meditation | Control | There were no adverse events in the intervention group | There were no adverse events in the control group | Quote: "No adverse events were observed." |
Tsai 2016 | Acupressure | Sham acupressure | Adverse events in the intervention group were reported: localized erythema (2/14), pruritus (2/14), infection (0/14). There were no serious adverse events in the intervention group |
There were neither adverse events nor serious adverse events in the control group | Quote: "No serious adverse events were reported. In the intervention group, we observed localized erythema below the non‐woven adhesive plaster after early treatment in two patients, who withdrew during the study due to an intolerable pruritus reaction. No patient was found to have an infection. No adverse events were reported for patients in the sham group." |
Yurtkuran 2007 | Exercise | Control | There were no adverse events in the intervention group | There were no adverse events in the control group | Quote: "No side‐effects were seen". |
Footnotes: L‐DOPS: L‐threo‐3,4‐dihydroxyphenylserine; C.E.R.A.: Continuous Erythropoietin Receptor Activator; EPO alfa: epoetin alfa; CBT: cognitive‐behavioral therapy |