Patients experiencing adverse events during randomized and extension treatment
| . | Time interval, months of miglustat treatment . | ||||
|---|---|---|---|---|---|
| 0 to 6 . | over 6 to 12 . | over 12 to 18 . | over 18 to 24 . | Overall . | |
| Subjects at beginning of time interval | 34 | 28 | 26 | 19 | 34 |
| Subjects with at least 1 adverse event during time interval, no. patients (%) | 34 (100) | 27 (96) | 25 (96) | 18 (95) | 28 (100) |
| Gastrointestinal disorders, no. patients (%) | 32 (94) | 15 (54) | 14 (54) | 11 (58) | 32 (94) |
| Diarrhea | 30 (88) | 14 (50) | 9 (35) | 8 (42) | 30 (88) |
| Flatulence | 14 (41) | 6 (21) | 6 (23) | 4 (21) | 17 (50) |
| Abdominal pain | 13 (38) | 8 (29) | 6 (23) | 4 (21) | 16 (47) |
| Constipation | 6 (18) | 3 (11) | 2 (8) | 2 (11) | 8 (24) |
| Nausea | 3 (9) | 1 (4) | 2 (8) | 2 (11) | 5 (15) |
| Vomiting | 1 (3) | 2 (7) | 2 (8) | 0 | 5 (15) |
| Nervous system disorders, no. patients (%) | 12 (62) | 7 (25) | 6 (23) | 4 (21) | 22 (65) |
| Tremor | 10 (29) | 2 (7) | 3 (12) | 3 (16) | 12 (35) |
| Dizziness | 8 (24) | 0 | 1 (4) | 0 | 9 (26) |
| Headache | 8 (24) | 2 (7) | 1 (4) | 1 (5) | 8 (24) |
| Fatigue | 5 (15) | 6 (21) | 4 (15) | 1 (5) | 9 (26) |
| Weakness | 7 (21) | 2 (7) | 2 (8) | 1 (5) | 9 (26) |
| Decreased weight, no. patients (%) | 23 (68) | 25 (89) | 21 (81) | 16 (84) | 28 (82) |
| Musculoskeletal and connective tissue disorders, no. patients (%) | 13 (38) | 9 (32) | 7 (27) | 5 (26) | 20 (59) |
| Respiratory, thoracic, and mediastinal disorders, no. patients (%) | 4 (12) | 5 (18) | 2 (8) | 3 (16) | 10 (29) |
| Skin and subcutaneous tissue disorders, no. patients (%) | 6 (18) | 6 (21) | 4 (15) | 2 (11) | 9 (26) |
| . | Time interval, months of miglustat treatment . | ||||
|---|---|---|---|---|---|
| 0 to 6 . | over 6 to 12 . | over 12 to 18 . | over 18 to 24 . | Overall . | |
| Subjects at beginning of time interval | 34 | 28 | 26 | 19 | 34 |
| Subjects with at least 1 adverse event during time interval, no. patients (%) | 34 (100) | 27 (96) | 25 (96) | 18 (95) | 28 (100) |
| Gastrointestinal disorders, no. patients (%) | 32 (94) | 15 (54) | 14 (54) | 11 (58) | 32 (94) |
| Diarrhea | 30 (88) | 14 (50) | 9 (35) | 8 (42) | 30 (88) |
| Flatulence | 14 (41) | 6 (21) | 6 (23) | 4 (21) | 17 (50) |
| Abdominal pain | 13 (38) | 8 (29) | 6 (23) | 4 (21) | 16 (47) |
| Constipation | 6 (18) | 3 (11) | 2 (8) | 2 (11) | 8 (24) |
| Nausea | 3 (9) | 1 (4) | 2 (8) | 2 (11) | 5 (15) |
| Vomiting | 1 (3) | 2 (7) | 2 (8) | 0 | 5 (15) |
| Nervous system disorders, no. patients (%) | 12 (62) | 7 (25) | 6 (23) | 4 (21) | 22 (65) |
| Tremor | 10 (29) | 2 (7) | 3 (12) | 3 (16) | 12 (35) |
| Dizziness | 8 (24) | 0 | 1 (4) | 0 | 9 (26) |
| Headache | 8 (24) | 2 (7) | 1 (4) | 1 (5) | 8 (24) |
| Fatigue | 5 (15) | 6 (21) | 4 (15) | 1 (5) | 9 (26) |
| Weakness | 7 (21) | 2 (7) | 2 (8) | 1 (5) | 9 (26) |
| Decreased weight, no. patients (%) | 23 (68) | 25 (89) | 21 (81) | 16 (84) | 28 (82) |
| Musculoskeletal and connective tissue disorders, no. patients (%) | 13 (38) | 9 (32) | 7 (27) | 5 (26) | 20 (59) |
| Respiratory, thoracic, and mediastinal disorders, no. patients (%) | 4 (12) | 5 (18) | 2 (8) | 3 (16) | 10 (29) |
| Skin and subcutaneous tissue disorders, no. patients (%) | 6 (18) | 6 (21) | 4 (15) | 2 (11) | 9 (26) |