TABLE 4.
Follow-up time points | ||||||
---|---|---|---|---|---|---|
T1 (n = 429) | T2 (n = 150) | T3 (n = 98) | T4 (n = 71) | T5 (n = 77) | T6 (n = 82) | |
No. of patients (%) | ||||||
Central nervous system | ||||||
Confusion | 45 (10) | 16 (11) | 11 (11) | 11 (15) | 9 (12) | 8 (10) |
Disorientation | 10 (2) | 6 (4) | 5 (5) | 1 (1) | 2 (3) | 2 (2) |
Impaired attention | 60 (14) | 31 (21) | 20 (20) | 6 (9) | 7 (9) | 12 (15) |
Dizziness | 38 (9) | 13 (9) | 14 (14) | 6 (9) | 8 (10) | 11 (13) |
Increased awareness | 60 (14) | 21 (14) | 13 (13) | 12 (17) | 11 (14) | 13 (16) |
Decreased awareness | 29 (7) | 13 (9) | 3 (3) | 4 (6) | 5 (7) | 6 (7) |
Decreased physical sensation | 17 (4) | 12 (8) | 5 (5) | 1 (1) | 2 (3) | 4 (5) |
Intoxication feeling | 13 (3) | 40 (5) | 30 (5) | 31 (5) | 30 (6) | 30 (6) |
Impaired balance | 37 (9) | 14 (9) | 10 (10) | 6 (9) | 4 (5) | 9 (11) |
Fatigue | 196 (46) | 76 (51) | 51 (52) | 31 (44) | 39 (51) | 36 (44) |
Impaired memory | 79 (18) | 36 (24) | 20 (20) | 14 (20) | 18 (23) | 17 (21) |
Impaired coordination | 19 (4) | 7 (5) | 7 (7) | 3 (4) | 1 (1) | 6 (7) |
Impaired speech | 23 (5) | 9 (6) | 1 (1) | 4 (6) | 1 (1) | 4 (5) |
Gastrointestinal | ||||||
Abdominal discomfort | 64 (15) | 22 (15) | 16 (16) | 13 (18) | 12 (16) | 17 (21) |
Abdominal pain | 55 (13) | 20 (13) | 14 (14) | 14 (20) | 11 (14) | 17 (21) |
Heartburn | 30 (7) | 15 (10) | 9 (9) | 9 (13) | 7 (9) | 8 (10) |
Nausea | 54 (13) | 19 (13) | 14 (14) | 8 (11) | 14 (18) | 18 (22) |
Vomiting | 15 (4) | 5 (3) | 4 (4) | 1 (1) | 2 (3) | 1 (1) |
Diarrhea | 31 (7) | 16 (11) | 8 (8) | 6 (9) | 7 (9) | 11 (13) |
Decreased appetite | 64 (15) | 26 (17) | 12 (12) | 9 (13) | 10 (13) | 14 (17) |
Increased appetite | 102 (24) | 33 (22) | 19 (19) | 17 (24) | 15 (19) | 16 (20) |
Sweet cravings | 97 (23) | 33 (22) | 21 (21) | 19 (27) | 16 (21) | 23 (28) |
Bad taste | 46 (11) | 15 (10) | 9 (9) | 9 (13) | 4 (5) | 7 (9) |
Thirst | 135 (31) | 52 (35) | 34 (35) | 26 (37) | 21 (27) | 31 (38) |
Dry mouth | 163 (38) | 67 (45) | 35 (36) | 32 (45) | 31 (40) | 43 (52) |
Psychological | ||||||
Unusual thinking | 23 (5) | 5 (3) | 5 (5) | 3 (4) | 3 (4) | 4 (5) |
Anxiety | 41 (10) | 16 (11) | 15 (15) | 6 (9) | 5 (7) | 11 (13) |
Dysphoria | 84 (20) | 24 (16) | 18 (18) | 11 (15) | 11 (14) | 15 (18) |
Hyperactivity | 18 (4) | 7 (5) | 1 (1) | 1 (1) | 0 | 3 (4) |
Euphoria | 18 (4) | 3 (2) | 3 (3) | 4 (6) | 4 (5) | 7 (9) |
Loss of time sensation | 27 (6) | 10 (7) | 6 (6) | 1 (1) | 1 (1) | 8 (10) |
Forgetfulness | 69 (16) | 27 (18) | 12 (12) | 11 (15) | 14 (18) | 19 (23) |
Nervousness | 65 (15) | 25 (17) | 12 (12) | 5 (7) | 11 (14) | 19 (23) |
Stress | 71 (17) | 28 (19) | 18 (18) | 15 (21) | 14 (18) | 12 (15) |
Tantrums | 29 (7) | 13 (9) | 7 (7) | 5 (7) | 5 (7) | 11 (13) |
Musculoskeletal | ||||||
Joint pain | 76 (18) | 28 (19) | 20 (20) | 16 (23) | 13 (17) | 16 (20) |
Limb weakness | 58 (14) | 19 (13) | 15 (15) | 6 (9) | 6 (8) | 9 (11) |
Tremor | 25 (6) | 9 (6) | 7 (7) | 4 (6) | 7 (9) | 6 (7) |
Spasms | 41 (10) | 14 (9) | 15 (15) | 4 (6) | 5 (7) | 8 (10) |
Cardiovascular | ||||||
Palpitations | 42 (10) | 7 (5) | 6 (6) | 2 (3) | 4 (5) | 6 (7) |
Visual | ||||||
Blurred vision | 33 (8) | 15 (20) | 9 (9) | 5 (7) | 4 (5) | 11 (13) |
Red eyes | 79 (18) | 39 (26) | 26 (27) | 12 (17) | 18 (23) | 21 (26) |
Dry eyes | 69 (16) | 33 (22) | 19 (19) | 14 (20) | 16 (21) | 22 (27) |
Miscellaneous | ||||||
Headaches | 3 (1) | 0 | 0 | 0 | 0 | 0 |
Tinnitus | 0 | 1 (<1) | 0 | 0 | 0 | 0 |
Energy decrease | 0 | 1 (<1) | 0 | 0 | 0 | 0 |
Flu like symptoms | 0 | 0 | 0 | 0 | 0 | 1 (1) |
Hypoglycemia | 1 (<1) | 0 | 0 | 0 | 0 | 0 |
T1-T6, one to six months follow ups, respectively; AEs list comprised based on the report by Aviram et al., (Aviram and Samuelly Leichtag 2017); Miscellaneous AEs were reported as text as explanation to "other AEs".