Table 2.
Serious adverse events
| Trial | Experimental intervention | Type and number of serious adverse events (experimental group) | Proportion of participants with a serious adverse event (experimental group) | Type and number of serious adverse events (control group) | Proportion of participants with a serious adverse event (control group) |
| Bronowicki 2013a1 | Asunaprevir | 1 abdominal pain, 1 lung neoplasm malignant, 1 cytolytic hepatitis, and 2 unspecified events | 5 out of 36 | None reported | 0 out of 11 |
| Bronowicki 2014 | Asunaprevir | 2 deaths and 14 unspecified events | 16 out of 177 | 3 unspecified events | 3 out of 61 |
| Nelson 2012a1 | Balapiravir | Many events but only a few were specified: 3 deaths, 10 haematological, 10 infection, 8 eye disorders | 49 out of 432 | Many events but not all were specified: 2 infections, 1 death | 9 out of 72 |
| Tatum 2015a1 | Beclabuvir | 1 anaemia, 1 constipation, 1 febrile neutropenia, 1 leukopenia | 1 out of 26 | 1 serotonin syndrome | 1 out of 13 |
| Bacon 2011a1 | Boceprevir | 5 anaemia, 1 angina pectoris, 1 atrial fibrillation, 1 coronary artery disease, 1 myocardial infarction, 1 myopericarditis, 2 abdominal pain, 1 constipation, 1 diarrhoea, 1 gastritis, 1 irritable bowel syndrome, 1 oesophageal varices haemorrhage, 1 pancreatitis acute, 1 pancreatitis necrotising, 1 peptic ulcer, 1 asthenia, 3 chest pain, 1 oedema peripheral, 1 pyrexia, 1 cholecystitis, 3 appendicitis, 1 bronchopneumonia, 1 catheter site infection, 1 gastroenteritis viral, 1 pneumonia, 1 lower limb fracture, 1 overdose, 1 decreased appetite, 1 dehydration, 1 hyperglycaemia, 1 back pain, 2 intervertebral disc protrusion, 1 pain in extremity, 1 hepatic neoplasm malignant, 1 hepatic encephalopathy, 1 sciatica, 1 syncope, 1 bipolar disorder, 1 completed suicide, 4 depression, 2 homicidal ideation, 5 suicidal ideation, 2 dyspnoea, 1 pleuritic pain, 1 pneumothorax, 1 abdominal hernia repair, 1 deep vein thrombosis, 1 phlebitis | 39 out of 323 | 2 chest pain, 1 cholelithiasis, 1 gastroenteritis | 4 out of 80 |
| Flamm 2013 | Boceprevir | 1 coronary artery disease, 1 diarrhoea, 1 asthenia, 1 pyrexia, 2 pneumonia, 2 syncope, 1 suicidal ideation, 1 deep vein thrombosis, 1 neutropenia, 1 thrombocytopenia, 1 cardiac failure, 1 upper gastrointestinal haemorrhage , 1 multi‐organ failure, 1 bronchitis, 1 cellulitis, 1 chlamydia infection, 1 influenza, 1 pneumonia staphylococcal, 1 staphylococcal bacteraemia, 1 staphylococcal infection, 1 urosepsis, 1 gun shot wound, 2 hyponatraemia, 1 lethargy, 1 subarachnoid haemorrhage, 1 mental status changes | 18 out of 134 | 1 chest pain, 1 intervertebral disc protrusion, 1 abnormal behaviour, 1 irritability, 1 osteotomy, 1 foreign body, 1 neuralgia, 1 anxiety, 1 renal colic | 7 out of 67 |
| Isakov 2016 | Boceprevir | 14 neutropenia, 1 intestinal obstruction, 1 osteomyelitis chronic, 1 pneumonia, 1 diabetic ketoacidosis, 1 intervertebral disc protrusion, 1 transient ischaemic attack | 17 out of 159 | 4 neutropenia, 1 general disorders, 1 accidental overdose, 1 prostatitis, 2 hypertension | 9 out of 78 |
| Kwo 2010a1 | Boceprevir | 1 anaemia, 1 abdominal pain, 2 asthenia, 2 pyrexia, 2 pneumonia, 1 decreased appetite, 1 dehydration, 2 depression, 2 homicidal ideation, 3 suicidal ideation, 1 dyspnoea, 1 deep vein thrombosis, 3 nausea, 1 vomiting, 3 neutropenia, 1 multi‐organ failure, 2 cellulitis, 2 abdominal pain upper, 1 headache, 1 suicide attempt, 1 accidental overdose, 1 fall, 1 pulmonary embolism, 1 gastroenteritis, 1 erysipelas, 1 panic attack, 1 fatigue, 1 supraventricular tachycardia, 3 pancreatitis, 1 cerebrovascular accident, 1 hypoaesthesia, 1 anxiety, 1 retinal ischaemia, 1 neuropathy peripheral, 1 aggression, 1 scotoma, 1 hypovolaemia, 1 vulval abscess, 1 retinopathy, 1 inguinal hernia, 1 cervix carcinoma, 1 pericarditis, 1 paranoia, 1 neutrophil count decreased, 1 paraesthesia, 1 peritoneal haemorrhage, 1 deafness unilateral, 1 periodontal disease, 1 corneal infection, 1 pneumonia streptococcal, 1 drug toxicity, 1 blood amylase increased, 1 lipase increased, 1 basal cell carcinoma, 1 renal cell carcinoma | 40 out of 527 | 1 suicidal ideation, 1 breast cancer, 1 parathyroid tumour benign, 1 muscle spasms, 1 rib fracture, 1 contusion, 1 inguinal hernia, 1 diplopia, 1 staphylococcal sepsis, 1 animal bite, 1 hand fracture, 1 third nerve paralysis, 1 alcoholism, 1 dependence | 8 out of 104 |
| Pearlman 2014 | Boceprevir | 1 anaemia | 1 out of 49 | 1 anaemia | 1 out of 52 |
| Poordad 2011a1 | Boceprevir | 7 anaemia, 1 atrial fibrillation, 1 coronary artery disease, 2 abdominal pain, 1 gastritis, 1 pancreatitis acute, 5 chest pain, 4 pyrexia, 1 cholecystitis, 4 pneumonia, 1 overdose, 1 dehydration, 1 back pain, 1 intervertebral disc protrusion, 5 syncope, 1 completed suicide, 2 depression, 4 suicidal ideation, 1 dyspnoea, 1 nausea, 2 vomiting, 3 neutropenia, 3 thrombocytopenia, 2 bronchitis, 3 cellulitis, 1 staphylococcal infection, 1 hyponatraemia, 1 pancytopenia, 1 breast cancer, 1 malaise, 1 pneumonia pneumococcal, 1 haemoptysis, 1 road traffic accident, 1 suicide attempt, 1 pruritus, 1 rash erythematous, 1 dizziness, 2 pulmonary embolism, 1 haemorrhoids, 4 gastroenteritis, 1 general physical health deterioration, 1 hypertensive crisis, 1 colon cancer, 1 drug abuse, 2 hypokalaemia, 2 chest discomfort, 1 fatigue, 1 perirectal abscess, 1 acute myocardial infarction, 1 gastrointestinal haemorrhage, 1 aplasia pure red cell, 2 leukopenia, 1 atrial flutter, 1 cardiac arrest, 1 hypertrophic cardiomyopathy, 1 tachycardia, 1 deafness, 1 conjunctivitis, 1 optic neuropathy, 1 papilledema, 1 abdominal pain lower, 1 colonic polyp, 1 gastroesophageal reflux disease, 1 hematemesis, 1 haemorrhoidal haemorrhage, 1 Mallory‐weiss syndrome, 1 umbilical hernia, 1 sarcoidosis, 1 abscess, 1 abscess limb, 1 bacteraemia, 1 epiglottitis, 1 infected bites, 1 injection site infection, 1 scrotal abscess, 1 tracheobronchitis, 1 post procedural complication, 1 transfusion reaction, 1 vascular pseudoaneurysm, 1 wound dehiscence, 1 flank pain, 1 groin pain, 1 musculoskeletal chest pain, 1 bladder cancer, 1 pancreatic carcinoma, 1 prostate cancer, 1 carotid artery stenosis, 1 cerebral ischaemia, 1 motor neurone disease, 1 muscle spasticity, 1 affective disorder, 1 alcohol abuse, 1 anxiety, 1 psychiatric decompensation, 1 scrotal pain, 2 cough, 1 pleural fibrosis, 1 alcohol use, 1 laryngeal operation, 1 accelerated hypertension, 1 arterial thrombosis limb, 2 hypotension | 87 out of 734 | 1 anaemia, 1 myocardial infarction, 1 abdominal pain, 2 pyrexia, 1 cholecystitis, 1 appendicitis, 1 pneumonia, 1 hepatic neoplasm malignant, 1 completed suicide, 1 depression, 1 suicidal ideation, 1 pneumothorax, 2 cholelithiasis, 1 nausea, 1 vomiting, 1 cellulitis, 1 breast cancer, 1 colitis, 1 upper respiratory tract infection, 1 suicide attempt, 2 death, 1 accidental overdose, 1 dizziness, 1 loss of consciousness, 1 cholecystitis acute, 1 sinusitis, 2 pancreatitis, 1 leukocytosis, 1 cardiac arrest, 1 cardio‐respiratory arrest, 1 hypothyroidism, 1 cholelithiasis obstructive, 1 atypical mycobacterial infection, 1 diverticulitis, 1 enterocolitis infectious, 1 alcohol poisoning, 1 spinal fracture, 1 white blood cell count decreased, 1 lung adenocarcinoma, 1 prostate cancer, 1 hypoaesthesia, 1 affective disorder, 1 bipolar disorder, 1 drug dependence, 1 intentional self‐injury, 1 personality disorder, 1 glomerulonephritis minimal lesion, 1 renal tubular necrosis, 1 physical assault, 1 cholecystectomy, 1 skin neoplasm excision | 31 out of 363 |
| Silva 2013a1 | Boceprevir | None reported | 0 out of 28 | 1 atrial fibrillation | 1 out of 10 |
| Sulkowski 2013a | Boceprevir | 3 anaemia, 2 pneumonia, 1 syncope, 1 depression, 1 deep vein thrombosis, 1 lymphadenopathy, 1 renal failure acute, 2 pulmonary embolism, 1 arthralgia, 1 sinusitis, 1 urinary tract infection, 1 lung infection pseudomonal, 1 pelvic inflammatory disease, 1 pulmonary hypertension, 1 suicide attempt | 11 out of 64 | 2 anaemia, 1 overdose, 1 cholelithiasis, 1 abdominal pain upper, 1 meniscus lesion, 1 pancreatitis, 1 post procedural infection, 1 renal failure, 1 cholecystectomy, 1 vulval abscess, 1 ventricular fibrillation, 1 ligament rupture, 1 lactic acidosis, 1 respiratory failure | 7 out of 34 |
| Dore 2015a1 | Daclatasvir | 1 hepatic neoplasm malignant, 1 rectal ulcer haemorrhage, 1 gastrointestinal inflammation, 1 adhesion, 1 biliary colic, 1 hyperbilirubinaemia, 1 appendiceal abscess, 1 tonsil cancer | 6 out of 196 | 1 abdominal pain upper, 1 epicondylitis, 1 conversion disorder | 3 out of 100 |
| COMMAND‐1 2015a1 | Daclatasvir | 1 anaemia, 1 abdominal pain, 1 gastritis, 1 chest pain, 2 pneumonia, 1 overdose, 1 syncope, 2 depression, 2 suicidal ideation, 1 dyspnoea, 1 bronchitis, 1 peritonitis, 1 rash generalised, 1 febrile neutropenia, 1 aplastic anaemia, 1 auricular perichondritis, 2 gastric ulcer haemorrhage, 1 death, 1 bile duct stone, 1 clostridium difficile, 1 furuncle, 1 carbuncle, 1 oral herpes, 1 accidental overdose, 2 falls, 1 bursitis, 1 rhabdomyolysis, 1 muscle spasms, 1 costochondritis, 1 dizziness, 1 loss of consciousness, 1 adjustment disorder, 1 hypomania, 1 mental disorder, 1 substance‐induced psychotic disorder, 1 schizophrenia, paranoid type | 25 out of 317 | 2 anaemia, 1 atrial fibrillation, 1 pneumonia, 1 pyelonephritis, 1 haemoglobin decreased, 1 epistaxis, 1 electrocardiogram change, 1 neutrophil count decreased, 1 myalgia, 1 aphasia, 1 paraesthesia | 6 out of 78 |
| Izumi 2014a1 | Daclatasvir | 1 pancreatitis acute, 1 back pain | 2 out of 34 | None reported | 0 out of 8 |
| Pol 2012 | Daclatasvir | 1 anaemia, 1 chest pain, 2 syncope, 1 bronchitis, 1 epistaxis | 3 out of 36 | None reported | 0 out of 12 |
| Dauphine 2015a1 | Danoprevir | 28 unspecified SAEs and 2 deaths | 29 out of 373 | 1 unspecified SAE | 1 out of 44 |
| Forestier 2011a1 | Danoprevir | 1 benign paroxysmal vertigo | 1 out of 40 | None reported | 0 out of 8 |
| Forestier 2011b | Danoprevir | 1 gastroenteritis viral | 1 out of 47 | None reported | 0 out of 12 |
| Gane 2011 | Danoprevir | 1 altered mood | 1 out of 25 | None reported | 0 out of 5 |
| ATLAS 2013 | Danoprevir | 14 SAEs but not specified, 1 death | 15 out of 194 | 6 SAEs but not specified | 6 out of 31 |
| Larrey 2013 | Deleobuvir | 1 drug eruption | 1 out of 46 | None reported | 0 out of 14 |
| Larrey 2012 | Deleobuvir | 1 syncope, 1 rash maculo‐papular, 1 umbilical hernia | 3 out of 49 | None reported | 0 out of 8 |
| STARTverso‐2 2014a1 | Faldaprevir | 2 anaemia, 1 angina pectoris, 2 diarrhoea, 1 oesophageal varices haemorrhage, 1 cholecystitis, 2 pneumonia, 1 dehydration, 1 back pain, 1 intervertebral disc protrusion, 1 bipolar disorder, 1 depression, 1 suicidal ideation, 1 dyspnoea, 2 nausea, 3 vomiting, 2 neutropenia, 1 thrombocytopenia, 1 cellulitis, 1 mental status changes, 1 pancytopenia, 1 breast cancer, 1 malaise, 2 rash, 2 sepsis, 1 suicide attempt, 1 renal failure acute, 1 rash maculo‐papular, 1 accidental overdose, 1 muscle spasm, 1 tibia fracture, 1 contusion, 1 pulmonary embolism, 2 abortion spontaneous, 1 hypokalaemia, 1 subcutaneous abscess, 1 acute myocardial infarction, 1 pancreatitis, 1 umbilical hernia, 1 diverticulitis, 1 cerebral ischaemia, 1 drug dependence, 1 personality disorder, 1 epidermolysis, 1 ascitis, 1 duodenal ulcer haemorrhage, 1 large intestine perforation, 1 hepatic cirrhosis, 2 hepatic failure, 1 hypersensitivity, 1 infective chondritis, 1 vulval abscess, 1 fibula fracture, 1 jaw fracture, 1 ligament sprain, 1 hypocalcaemia, 1 hyponatraemia, 1 hepatocellular carcinoma, 1 papillary thyroid cancer | 47 out of 525 | 1 anaemia, 2 depression, 1 suicidal ideation, 1 bile duct stone, 1 subcutaneous abscess, 1 optic ischaemic neuropathy, 1 laceration, 1 mental status change | 8 out of 132 |
| STARTVerso‐1 2015a1 | Faldaprevir | 3 anaemia, 1 atrial fibrillation, 1 myocardial infarction, 1 asthenia, 1 chest pain, 1 pyrexia, 1 bronchopneumonia, 1 pneumonia, 1 sciatica, 2 vomiting, 1 thrombocytopenia, 1 pancytopenia, 1 headache, 2 rash, 1 drug eruption, 1 dizziness, 1 haemorrhoids, 1 psychotic disorder, 1 urinary tract infection, 1 diabetes mellitus, 1 parapsoriasis, 1 pancreatitis, 1 histiocytosis haematophagic, 1 cerebrovascular accident, 1 muscular weakness, 1 epistaxis, 1 leukopenia, 1 sarcoidosis, 1 hypotension, 1 idiopathic thrombocytopenic purpura, 1 optic ischaemic neuropathy, 1 hypersensitivity, 1 hypoparathyroidism, 1 retinopathy, 1 subdural hematoma, 1 cervix carcinoma, 1 cubital tunnel syndrome, 1 dyspnoea exertional | 34 out of 520 | 1 anaemia, 1 cholecystitis, 1 gun shot wound, 1 rash maculo‐papular, 1 diverticulitis, 1 inguinal hernia, 1 hepatic lesion, 1 polymyositis, 1 blister | 8 out of 132 |
| STARTverso‐3 2013a1 | Faldaprevir | 5 anaemia, 1 atrial fibrillation, 1 abdominal pain, 5 diarrhoea, 1 pancreatitis acute, 1 asthenia, 1 chest pain, 8 pyrexia, 2 appendicitis, 1 gastroenteritis viral, 2 pneumonia, 1 decreased appetite, 1 dehydration, 1 back pain, 1 hepatic neoplasm malignant, 2 cholelithiasis, 1 biliary colic, 2 hyperbilirubinaemia, 3 nausea, 2 vomiting, 1 thrombocytopenia, 1 cellulitis, 1 bradycardia, 2 presyncope, 2 malaise, 2 headache, 2 sepsis, 1 rash erythematous, 1 rash generalised, 1 fall, 1 multiple injuries, 1 haematochezia , 1 peritonitis bacterial, 1 congestive cardiac failure, 1 gastroenteritis, 1 hypertensive crisis, 1 hypokalaemia, 1 fatigue, 1 pancreatitis, 1 coma, 1 renal colic, 1 leukopenia, 1 cardio‐respiratory arrest, 1 anxiety, 1 psychiatric decompensation, 2 hypotension, 1 viral infection, 2 ascitis, 1 hepatic failure, 1 hypoglycaemia, 1 haemolytic anaemia, 1 keratosis follicular, 1 oral lichen planus, 1 peritoneal haemorrhage, 1 salivary gland calculus, 1 hepatorenal failure, 2 jaundice, 1 streptococcal infection, 1 blood lactate dehydrogenase increased, 1 international normalised ratio abnormal, 1 metabolic acidosis, 1 fasciitis, 1 joint instability, 1 musculoskeletal discomfort, 1 haemothorax, 1 venous thrombosis | 54 out of 599 | 1 depression, 1 pleural effusion | 1 out of 78 |
| Nishiguchi 2014a1 | Faldaprevir | 1 abdominal pain upper | 1 out of 35 | 1 abdominal pain | 1 out of 8 |
| Manns 2011 | Faldaprevir | 1 asthenia, 1 cataract , 1 hypoalbuminaemia, 1 metabolic disorder, 1 ascites | 4 out of 88 | None reported | 0 out of 8 |
| Sulkowski 2013a | Faldeprevir | 4 anaemia, 1 angina pectoris, 1 myocardial infarction, 1 diarrhoea, 1 asthenia, 1 chest pain, 1 oedema peripheral, 4 pyrexia, 1 cholecystitis, 1 pneumonia, 2 dehydration, 1 intervertebral disc protrusion, 2 syncope, 1 depression, 1 nausea, 2 vomiting, 1 thrombocytopenia, 1 upper gastrointestinal haemorrhage, 1 influenza, 1 lower respiratory tract infection, 2 photosensitivity reaction, 1 upper respiratory tract infection, 2 headache, 1 rash, 1 road traffic accident, 2 suicide attempt, 3 drug eruption, 2 rash maculo‐papular, 1 rash erythematous, 2 febrile neutropenia, 1 oral herpes, 1 pulmonary embolism, 1 pyelonephritis, 1 cataract, 1 anaemia haemolytic autoimmune, 1 lymphopenia, 1 microvascular angina, 1 prinzmetal angina, 1 anal fistula, 1 haemorrhoids, 1 mouth ulceration, 1 rectal haemorrhage, 1 chest discomfort, 1 fatigue, 1 mucosal inflammation, 1 gallbladder polyp, 1 cryoglobulinaemia, 1 anal abscess, 1 ear infection, 2 H1N1 influenza, 1 infected skin ulcer, 1 lymphangitis, 1 perirectal abscess, 1 pharyngitis, 1 subcutaneous abscess, 1 superinfection bacterial, 1 urinary tract infection, 1 diabetes mellitus, 1 ischaemic stroke, 1 acute psychosis, 1 depressed mood, 1 calculus ureteric, 1 endometrial hyperplasia, 1 dermatitis atopic, 1 eczema, 1 erythema multiforme, 1 lichen planus, 1 palmar‐plantar erythrodysaesthesia syndrome, 1 parapsoriasis, 1 pruritus allergic, 1 rash pruritic, 1 appendicectomy | 61 out of 641 | 1 headache, 1 photophobia, 1 cyst, 1 benign salivary gland neoplasm, 1 migraine | 2 out of 71 |
| Jacobson 2010 | Filibuvir | 1 blood creatinine increased, 1 chronic obstructive pulmonary disease, 1 pulmonary embolism | 3 out of 27 | 1 thyroiditis, 1 gait disturbance | 2 out of 8 |
| Rodriguez‐Torres 2014b1 | Filibuvir | 1 anaemia, 1 appendicitis, 1 rectal ulcer haemorrhage, 1 craniocerebral injury, 1 vertigo, 1 vestibular disorder, 1 haematochezia, 1 peritonitis bacterial, 1 lymph node tuberculosis, 1 scapula fracture, 1 blood urea nitrogen/creatinine increased, 1 gastric cancer, 1 rectal cancer, 1 abortion spontaneous, 1 cardiac necrosis, 1 pyoderma gangrenosum, 1 depression, 1 breast cancer, 1 chronic obstructive pulmonary disease, 1 lung neoplasm malignant, 1 fall, 1 loss of consciousness, 1 bacterial abscess CNS, 1 actinomyces test positive, 1 pulmonary calcification | 20 out of 192 | 1 neutropenia, 1 sepsis, 1 pulmonary embolism, 1 cerebral haemorrhage, 1 ecchymosis, 1 Appendicitis perforated | 6 out of 96 |
| Lawitz 2013b | GS‐9451 | 1 death, 1 heroin overdose | 1 out of 33 | None reported | 0 out of 8 |
| Gardner 2014a | GSK2336805 | 1 pneumonia, 1 upper lobe cavitary lesion | 1 out of 11 | None reported | 0 out of 4 |
| Lalezari 2013 | IDX‐184 | 1 pancreatitis, 1 acute cholecystitis | 2 out of 65 | 1 agitation | 1 out of 16 |
| Gane 2010 | Mericitabine/danoprevir | 1 multiple drug overdose, 1 ankle fracture | 2 out of 73 | None reported | 0 out of 14 |
| Feld 2015 | Mericitabine | 1 nephrolithiasis, 1 porphyria non‐acute | 2 out of 102 | 1 arthritis infective | 1 out of 49 |
| JUMP‐C 2013 | Mericitabine | 6 SAEs but not specified | 5 out of 81 | 4 SAEs but not specified | 3 out of 85 |
| De Bruijne 2010a1 | Narlaprevir | 1 pyrexia, 1 elevated CRP | 1 out of 32 | None reported | 0 out of 8 |
| Muir 2014 | Odalasvir (ACH‐3102) and sovaprevir | 1 non‐cardiac chest pain | 1 out of 20 | None reported | 0 out of 10 |
| Zeuzem 2014a | Paritaprevir (ABT‐450)/r–ombitasvir | 1 pneumonia, 1 nausea, 1 vomiting, 1 bradycardia, 1 chronic obstructive pulmonary disease, 1 renal failure acute, 1 dizziness, 1 intestinal obstruction, 1 cerebrovascular accident, 1 bile duct stone, 1 calculus ureteric, 1 angioedema | 9 out of 393 | 1 atrial fibrillation | 1 out of 97 |
| Anderson 2014a1 | Paritaprevir/ABT‐072/dasabuvir | 1 haemorrhoids, 1 malignant melanoma | 2 out of 63 | None reported | 0 out of 11 |
| Feld 2014 | Paritaprevir/ombitasvir | 1 anaemia, 1 abdominal pain, 1 diarrhoea, 1 cholecystitis, 1 appendicitis, 1 overdose, 1 sinus tachycardia, 1 ventricular extrasystoles, 1 nausea, 1 vomiting, 1 chills, 1 non‐cardiac chest pain, 1 lobar pneumonia, 1 postoperative wound infection, 1 lumbar vertebral fracture, 1 non‐small cell lung cancer, 1 encephalopathy, 1 acute respiratory failure, 1 hypoxia, 1 mediastinal mass, 1 aortic stenosis, 1 biliary colic, 1 subcutaneous abscess | 12 out of 630 | None reported | 0 out of 158 |
| Pockros 2008a1 | R1626 | 6 SAEs but not specified | 6 out of 84 | 1 SAE but not specified | 1 out of 20 |
| Forns 2014 | Simeprevir | 1 abdominal pain, 1 pyrexia, 1 appendicitis, 2 pneumonia, 1 depression, 1 dyspnoea, 1 cholelithiasis, 1 anaemia haemolytic autoimmune, 1 pancytopenia, 1 angina pectoris, 1 bradycardia, 1 myocardial ischaemia, 1 hepatitis, 1 endocarditis, 1 lower respiratory tract infection, 1 septic shock, 1 breast cancer, 1 Guillain‐Barre syndrome, 1 presyncope, 1 confusional state, 1 vaginal haemorrhage, 1 chronic obstructive pulmonary disease, 1 respiratory acidosis, 1 photosensitivity reaction | 14 out of 260 | 1 atrial fibrillation, 1 depression, 1 bronchitis, 1 hypercalcaemia, 1 head injury, 1 bacterial prostatitis, 1 pericarditis, 1 infection, 1 inguinal hernia, 1 neuropathy peripheral, 1 arthritis infective, 1 headache | 11 out of 133 |
| Fried 2013 | Simeprevir | 1 cholecystitis, 1 intervertebral disc protrusion, 1 depression, 1 nausea, 1 breast cancer, 1 hyperthyroidism, 1 ocular vasculitis, 1 abdominal pain upper, 1 colitis, 1 small intestinal obstruction, 1 malaise, 1 incision site cellulitis, 1 necrotising fasciitis, 1 perihepatic abscess, 1 pneumonia pneumococcal, 1 upper respiratory tract infection, 1 post‐procedural bile leak, 1 malnutrition, 1 type 1 diabetes mellitus, 1 spinal disorder, 1 parathyroid tumour benign, 1 headache, 1 haemoptysis, 1 cutaneous vasculitis, 1 hypertension | 20 out of 309 | 1 myocardial infarction, 1 myopericarditis, 1 asthenia, 1 appendicitis, 1 vomiting, 1 chronic obstructive pulmonary disease, 1 headache, 1 subcutaneous abscess, 1 vulval abscess, 1 myositis, 1 ovarian neoplasm | 10 out of 77 |
| DRAGON 2014a1 | Simeprevir | 1 subarachnoid haemorrhage, 1 malaise, 1 cerebral infarction, 1 vulvar erosion, 1 rash, 1 incorrect dose administered | 5 out of 79 | None reported | 0 out of 13 |
| Hoeben 2015a1 | Simeprevir | 1 depression, 1 non‐cardiac chest pain, 1 angina unstable, 1 nephrolithiasis, 1 ureteric stenosis, 1 colitis ischaemic, 1 incision site infection, 1 craniocerebral injury, 1 foot fracture, 1 meniscus lesion, 1 multiple injuries, 1 rib fracture, 1 tibia fracture, 1 traumatic lung injury, 1 wound, 1 cholesterosis, 1 type 2 diabetes mellitus, 1 shock haemorrhagic | 10 out of 305 | 1 anaemia, 1 decreased appetite, 1 cholelithiasis, 1 contusion, 1 supraventricular tachycardia, 1 ligament sprain, 1 pain, 1 atypical pneumonia, 1 chronic hepatitis C, 1 pulmonary tuberculosis, 1 undifferentiated connective tissue disease, 1 brain neoplasm | 9 out of 152 |
| OPERA 2011a1 | Simeprevir | 1 sinus arrest, 1 erysipelas, 1 type 1 diabetes mellitus, 1 psychotic disorder, 1 drug abuse, 1 bronchitis, 1 exostosis, 1 toe deformity, 1 hyperthyroidism, 1 Bowen's disease, 1 neutropenia, 1 thrombocytopenia, 1 breast cancer, 1 sepsis, 1 cupulolithiasis, 1 pneumonia escherichia, 1 panic reaction | 13 out of 88 | 1 pneumonia, 1 sinusitis, 1 panic attack, 1 social stay hospitalisation, 1 pneumonia escherichia | 3 out of 28 |
| Manns 2014a | Simeprevir | 2 anaemia, 1 back pain, 1 syncope, 1 hyperthyroidism, 1 death, 1 muscle spasms, 1 colon cancer, 1 anal abscess, 1 urinary tract infection, 1 mixed deafness, 1 hyphaema, 1 visual impairment, 1 enterocutaneous fistula, 1 autoimmune hepatitis, 1 lymphadenitis bacteria, 1 fluid overload, 1 epilepsy, 1 memory impairment, 1 aggression | 16 out of 257 | 1 anaemia, 1 pancreatitis acute, 1 dehydration, 1 vomiting, 1 pancytopenia, 1 loss of consciousness, 1 angina unstable, 1 meniscus lesion, 1 pulmonary embolism, 1 cholecystitis acute, 1 drug abuse, 1 retinal ischaemia, 1 respiratory tract infection viral, 1 viral infection, 1 neuropathy peripheral, 1 thoracic outlet syndrome | 10 out of 134 |
| Pearlman 2015 | Simeprevir | None reported | 0 out of 58 | 1 liver decompensation | 1 out of 24 |
| ASPIRE 2014 | Simeprevir | 1 anaemia, 1 abdominal pain, 1 diarrhoea, 1 oedema peripheral, 2 cholecystitis, 1 pneumonia, 1 overdose, 2 dehydration, 1 intervertebral disc protrusion, 1 hepatic neoplasm malignant, 2 vomiting, 1 non‐cardiac chest pain, 1 neutropenia, 2 cellulitis, 1 pancytopenia, 1 headache, 1 hypertension, 1 suicide attempt, 1 drug eruption, 2 clostridium difficile colitis, 1 nephrolithiasis, 1 pulmonary embolism, 1 rectal cancer, 1 sinusitis, 3 urinary tract infection, 1 diabetes mellitus, 1 migraine, 1 coma, 1 epistaxis, 1 alcohol abuse, 1 haemorrhagic anaemia, 1 cervix carcinoma, 1 periodontal disease, 1 enteritis, 1 gastro intestinal pain, 1 gingival infection, 1 lung infection, 1 meningitis bacterial, 1 pneumonia bordetella, 1 salpingitis, 1 thermal burn, 1 neurilemmoma benign, 1 brain injury, 1 cerebral haemorrhage, 1 vii nerve paralysis, 1 metrorrhagia, 1 pelvic adhesions | 31 out of 396 | 1 sciatica, 1 nausea, 1 vomiting, 1 lower respiratory tract infection, 1 haemorrhoids, 1 weight decreased, 1 histiocytosis haematophagic, 1 tuberculosis | 4 out of 66 |
| POSITRON 2013 | Sofosbuvir | 1 drug withdrawal syndrome, 1 non‐cardiac chest pain, 1 oedema peripheral, 1 pyrexia, 1 hypersensitivity, 1 abdominal abscess, 1 cellulitis, 2 overdose, 1 injury, 1 road traffic accident, 1 spinal compression fracture, 1 hypoglycaemia, 1 hepatic neoplasm malignant, 1 abnormal behaviour, 1 eczema | 11 out of 207 | 1 pancreatitis, 1 bile duct stone, 1 bronchitis | 2 out of 71 |
| Lawitz 2013a1 | Sofosbuvir | 1 retinal vein occlusion, 1 depression, 1 suicidal ideation, 1 lymphangitis, 1 acute myocardial infarction | 4 out of 95 | 1 chest pain, 1 electrocardiogram ST segment elevation | 1 out of 26 |
| FISSION 2013 | Sofosbuvir | 1 anaemia, 1 chest pain, 1 cellulitis, 1 chronic obstructive pulmonary disease, 1 urinary tract infection, 1 allergy to anthropod sting, 1 osteomyelitis chronic , 1 toxicity to various agents | 7 out of 256 | 1 pneumothorax, 1 breast cancer, 1 infection, 1 atrioventricular shock, 1 clavicle fracture, 1 rib fracture | 3 out of 243 |
| Rodriguez‐Torres 2013 | Sofosbuvir | 1 anaemia, 1 depression, 1 peripheral ischaemia, 1 pancreatitis acute | 4 out of 49 | 1 abdominal pain | 1 out of 14 |
| Feld 2015 | Sofosbuvir/velpatasvir | 1 bronchitis, 1 cellulitis, 1 influenza, 1 chronic obstructive pulmonary disease, 1 death, 1 gastroenteritis, 1 acute myocardial infarct, 1 ligament sprain, 1 foot abscess, 1 foot necrosis, 1 recurring appendicitis, 1 epileptic seizure, 1 rotator cuff syndrome, 1 lung cancer, 1 mania, 1 palpitations, 1 small bowel obstruction, 1 upper limb fracture, 1 vestibular neuronitis | 15 out of 624 | None reported | 0 out of 116 |
| Benhamou 2013a1 | Telaprevir | 1 cholelithiasis | 1 out of 16 | None reported | 0 out of 8 |
| Hezode 2009 | Telaprevir | 5 anaemia, 2 abdominal pain, 1 asthenia, 1 pyrexia, 1 back pain, 3 syncope, 3 depression, 2 dyspnoea, 1 nausea, 1 chills, 1 pancytopenia, 5 rash, 1 lymphadenopathy, 1 hydrocele, 1 retinal haemorrhage, 1 catheter‐related complication, 1 bacterial sepsis, 1 pneumonia, 1 herpes viral, 1 sepsis, 1 road traffic accident, 1 tendon rupture, 1 lung neoplasm malignant, 1 speech disorder, 1 disorientation, 1 emotional distress, 1 suicide attempt, 1 renal failure, 1 acute testicular swelling, 3 pruritis, 2 drug eruption, 2 rash maculo‐papular, 1 rash erythematous, 1 rash generalised, 1 toxic skin eruption, 1 urticaria, 1 splenectomy | 36 out of 241 | 2 anaemia, 1 angina pectoris, 1 syncope, 1 hyperthyroidism, 1 gastroenteritis, 1 haemorrhagic anaemia, 1 alcoholic pancreatitis, 1 paranoia, 1 uterine polyp | 8 out of 82 |
| ADVANCE 2011a1 | Telaprevir | 18 anaemia, 3 pneumonia, 3 syncope, 2 cellulitis, 5 rash, 3 psychiatric disorder, 2 musculoskeletal disorder, 2 cardiac disorder, 2 eye disorder, 3 hepatobiliary disorders, 2 vascular disorder | 64 out of 727 | 4 anaemia, 1 cellulitis, 3 psychiatric disorder, 3 musculoskeletal disorder, 2 cardiac disorder, 4 renal and urinary disorder, 1 eye disorder, 1 vascular disorder | 24 out of 361 |
| McHutchison 2009 | Telaprevir | 2 anaemia, 1 gastroenteritis viral, 1 dehydration, 2 depression, 1 non‐cardiac chest pain, 1 chronic obstructive pulmonary disease, 1 rash, 1 rash generalised, 1 furuncle, 1 colitis ischaemic, 1 acute myocardial infarction, 1 adrenal disorder, 2 scotoma, 1 retinal exudates, 1 retinal infarction, 1 bronchitis bacterial, 1 incisional hernia, 1 lumbar radiculopathy, 1 exfoliative rash | 18 out of 175 | 1 lobar pneumonia, 1 pancytopenia, 1 anxiety, 1 lymphadenitis bacteria, 1 deafness neurosensory | 4 out of 75 |
| McHutchison 2010 | Telaprevir | 6 anaemia, 1 pancreatitis acute, 1 gastroenteritis viral, 1 pneumonia, 1 dehydration, 1 back pain, 1 suicidal ideation, 2 cholelithiasis, 1 postoperative wound infection, 1 upper gastrointestinal haemorrhage, 1 confusional state, 2 small intestinal obstruction, 1 necrotising fasciitis, 1 pneumonia pneumococcal, 1 post‐procedural bile leak, 1 rash, 1 renal failure acute, 1 retinal detachment, 9 gastroenteritis, 1 cholecystitis acute, 1 sinusitis, 1 hypokalaemia, 1 eczema, 2 pancreatitis, 1 dermatitis, 1 diverticulitis, 1 alcohol abuse, 1 hypotension, 1 haemorrhagic anaemia, 1 idiopathic thrombocytopenic purpura, 1 cardiomyopathy, 1 diverticular perforation, 1 gastritis erosive, 1 abscess intestinal, 1 cholecystitis infective, 1 infected insect bite, 1 sepsis syndrome, 1 hypovolaemia, 1 B‐cell unclassifiable lymphoma low grade, 1 migraine with aura, 1 ruptured cerebral aneurysm, 1 neurogenic bladder, 1 lichenoid keratosis, 1 rash macular | 28 out of 339 | 1 anaemia, 1 pneumonia, 2 dehydration, 1 syncope, 1 depression, 1 non‐small cell lung cancer, 1 headache, 2 rash, 1 renal failure acute, 2 gastroenteritis, 1 renal tubular acidosis, 1 decubitus ulcer, 1 hematoma | 9 out of 114 |
| Sulkowski 2013a | Telaprevir | 1 myocardial infarction, 1 staphylococcal infection, 1 pyelonephritis acute, 1 haemolytic anaemia, 1 groin infection, 1 cellulitis staphylococcal, 1 staphylococcal abscess, 1 hypokalaemia, 1 hyponatraemia, 1 epididymitis, 1 non‐ cardiac chest pain | 7 out of 38 | 1 anaemia, 1 appendicitis, 1 peritonitis | 2 out of 22 |
| Zeuzem 2011a | Telaprevir | 13 anaemia, 1 febrile neutropenia, 2 pancytopenia, 1 thrombocytopenia , 3 acute myocardial infarction, 2 atrial fibrillation, 1 cardiac valve disease, 1 myocardial infarction, 1 supraventricular tachycardia, 1 sudden hearing loss, 1 Basedow's disease, 1 retinal detachment, 1 abdominal pain, 1 anal fissure, 1 caecitis, 1 gastrointestinal haemorrhage, 1 pancreatitis, 2 pancreatitis acute, 1 general physical health deterioration, 1 pyrexia, 1 appendicitis, 2 bronchitis, 1 erysipelas, 1 folliculitis, 1 Helicobacter gastritis, 1 pneumonia, 1 post‐procedural infection, 1 rectal abscess, 2 sepsis, 1 sinusitis, 1 tooth abscess, 2 urinary tract infection, 1 injection site reaction, 1 animal scratch, 1 ankle fracture, 1 femoral neck fracture, 1 multiple drug overdose, 1 blood corticotrophin decreased, 1 weight decreased, 1 anorexia, 1 diabetes mellitus, 1 bronchial carcinoma, 2 gastric cancer, 2 hepatic neoplasm malignant, 1 histiocytosis haematophagic, 1 lung neoplasm malignant, 1 lethargy, 1 subarachnoid haemorrhage, 2 syncope, 1 delirium, 1 depression, 1 insomnia, 1 substance abuse, 1 renal cyst, 1 renal failure, 1 urinary bladder polyp, 1 prostatitis, 1 pulmonary embolism, 1 dermatitis, 1 eczema , 1 erythema multiforme, 1 pruritus 1 pustular psoriasis, 1 rash, 2 toxic skin eruption, 1 orthostatic hypotension, 1 peripheral artery aneurysm | 65 out of 530 | 1 anaemia, 1 atrial fibrillation, 1 abdominal pain, 1 pneumonia, 1 colitis, 1 pyelonephritis, 1 cerebral thrombosis, 1 coma | 7 out of 132 |
| Manns 2012a1 | Vaniprevir | 1 appendicitis, 1 lobar pneumonia, 1 septic shock, 1 confusional state, 1 gastroenteritis, 1 cholecystitis acute, 1 empyema, 1 haemoglobin decreased, 1 myopathy | 8 out of 75 | 1 colon cancer | 1 out of 19 |
| Lawitz 2013c | Vaniprevir | 1 anaemia, 1 pneumonia, 1 syncope, 1 upper gastrointestinal haemorrhage, 1 cellulitis, 1 confusional state, 1 dizziness, 1 nephrolithiasis, 1 malignant melanoma, 3 retinal detachment, 1 joint dislocation, 1 congestive cardiac failure, 2 gastroenteritis, 1 femur fracture, 1 hyperglycaemia, 1 dermatomyositis, 1 retinal vascular thrombosis, 1 general physical health deterioration, 1 anaphylactic reaction, 1 pyelonephritis, 1 pyelonephritis acute, 1 carbon monoxide poisoning, 1 arthralgia, 1 arthritis infective, 1 completed suicide | 22 out of 229 | 1 hypertensive crisis | 1 out of 56 |
SAE: serious adverse events.