Table 2.
Incidence (patients, n, %) of treatment-emergent adverse events throughout the study (≥20% crude incidence in either treatment group during the core study and the extension).
| TEAE | Crude incidence, n (%) |
Episodes of TEAEs per patient, N1 (N2/n)a |
||
|---|---|---|---|---|
| Teriflunomide 7 mg (N=81) | Teriflunomide 14 mg (N=66) | Teriflunomide 7 mg (N=81) | Teriflunomide 14 mg (N=66) | |
| Any TEAE | 80 (98.8) | 66 (100) | 41.7 (3338/80) | 37.9 (2503/66) |
| Infections and infestations | 72 (88.9) | 56 (84.8) | 6.0 (431/72) | 7.5 (421/56) |
| Nasopharyngitis | 37 (45.7) | 35 (53.0) | 2.6 (96/37) | 1.9 (68/35) |
| Upper respiratory tract infection | 29 (35.8) | 29 (43.9) | 2.2 (64/29) | 2.2 (63/29) |
| Influenza | 22 (27.2) | 23 (34.8) | 1.4 (31/22) | 1.8 (41/23) |
| Urinary tract infection | 19 (23.5) | 15 (22.7) | 2.8 (54/19) | 2.9 (44/15) |
| Gastrointestinal disorders | 65 (80.2) | 50 (75.8) | 3.9 (253/65) | 3.6 (180/50) |
| Diarrhoea | 22 (27.2) | 25 (37.9) | 1.6 (36/22) | 1.6 (40/25) |
| Nausea | 21 (25.9) | 17 (25.8) | 1.6 (34/21) | 1.5 (25/17) |
| Investigationsa | 59 (72.8) | 53 (80.3) | 4.8 (281/59) | 5.5 (292/53) |
| Alanine aminotransferase increased | 24 (29.6) | 19 (28.8) | 1.9 (45/24) | 2.1 (39/19) |
| Aspartate aminotransferase increased | 10 (12.3) | 15 (22.7) | 1.9 (19/10) | 1.5 (22/15) |
| Nervous system disorders | 77 (95.1) | 61 (92.4) | 10.5 (805/77) | 8.5 (517/61) |
| Hypoaesthesia | 39 (48.1) | 33 (50.0) | 2.2 (86/39) | 2.3 (77/33) |
| Headache | 40 (49.4) | 26 (39.4) | 3.6 (144/40) | 2.5 (64/26) |
| Pallanesthesia | 27 (33.3) | 20 (30.3) | 1.7 (47/27) | 1.3 (26/20) |
| Sensory disturbance | 20 (24.7) | 19 (28.8) | 1.4 (28/20) | 1.3 (24/19) |
| Dizziness | 18 (22.2) | 14 (21.2) | 2.0 (36/18) | 2.5 (35/14) |
| Hyperreflexia | 19 (23.5) | 14 (21.2) | 1.7 (32/19) | 1.9 (27/14) |
| Multiple sclerosisb | 25 (30.9) | 13 (19.7) | 1.4 (36/25) | 1.2 (15/13) |
| Coordination abnormal | 20 (24.7) | 10 (15.2) | 1.5 (29/20) | 1.4 (14/10) |
| Psychiatric disorders | 45 (55.6) | 34 (51.5) | 2.5 (113/45) | 1.8 (61/34) |
| Insomnia | 28 (34.6) | 17 (25.8) | 1.4 (39/28) | 1.3 (22/17) |
| Depression | 20 (24.7) | 10 (15.2) | 1.4 (27/20) | 1.6 (16/10) |
| Skin and subcutaneous tissue disorders | 51 (63.0) | 42 (63.6) | 2.7 (136/51) | 2.6 (111/42) |
| Hair thinning/decreased hair densityc | 17 (21.0) | 18 (27.3) | 1.5 (26/17) | 1.4 (25/18) |
| Rash | 18 (22.2) | 11 (16.7) | 1.2 (22/18) | 1.9 (21/11) |
| Musculoskeletal and connective tissue disorders | 70 (86.4) | 53 (80.3) | 6.1 (424/70) | 5.7 (301/53) |
| Muscular weakness | 34 (42.0) | 25 (37.9) | 2.6 (88/34) | 2.2 (55/25) |
| Back pain | 28 (34.6) | 24 (36.4) | 1.5 (41/28) | 1.9 (46/24) |
| Pain in extremity | 37 (45.7) | 21 (31.8) | 2.2 (83/37) | 2.5 (52/21) |
| Paresthesia | 25 (30.9) | 20 (30.3) | 1.9 (48/25) | 1.9 (37/20) |
| Arthralgia | 27 (33.3) | 18 (27.3) | 1.9 (51/27) | 1.5 (27/18) |
| General disorders | 61 (75.3) | 52 (78.8) | 3.7 (228/61) | 3.3 (169/52) |
| Fatigue | 39 (48.1) | 32 (48.5) | 1.9 (75/39) | 2.2 (71/32) |
| Gait disturbance | 17 (21.0) | 11 (16.7) | 2.2 (38/17) | 1.2 (13/11) |
| Asthenia | 17 (21.0) | 8 (12.1) | 1.3 (22/17) | 1.1 (9/8) |
| Renal and urinary disorders | 33 (40.7) | 23 (34.8) | 2.5 (82/33) | 2.6 (60/23) |
| Micturition urgency | 17 (21.0) | 13 (19.7) | 1.4 (24/17) | 1.9 (25/13) |
| Serious TEAEsd | ||||
| Any serious TEAE | 29 (35.8) | 19 (28.8) | 1.2 (35/29) | 2.0 (38/19) |
| Hepatic enzyme increased | 5 (6.2) | 5 (7.6) | 1.0 (5/5) | 1.0 (5/5) |
| Alanine aminotransferase increased | 1 (1.2) | 2 (3.0) | 1.0 (1/1) | 1.5 (3/2) |
| Loss of consciousness | 1 (1.2) | 2 (3.0) | 1.0 (1/1) | 1.0 (2/2) |
| Neutropenia | 0 | 2 (3.0) | 0 (0/0) | 1.5 (3/2) |
| Pneumonia | 0 | 2 (3.0) | 0 (0/0) | 1.0 (2/2) |
| Multiple sclerosisb | 3 (3.7) | 0 | 1.0 (3/3) | 0 (0/0) |
| Breast cancer | 2 (2.5) | 0 | 1.0 (2/2) | 0 (0/0) |
TEAE: treatment-emergent adverse event.
Data presented by Medical Dictionary for Regulatory Activities (MedDRA) preferred term and by decreasing order of frequency in the 14 mg dose group. The number (N1) represents the number of TEAEs per patient. It is calculated as the ratio of the total number of TEAEs (N2) and the total number of patients with at least one TEAE (n).
Laboratory abnormalities reported as TEAEs were based on the investigator’s decision and/or on the following reporting thresholds (confirmed by a re-test): alanine aminotransferase ≥2x upper limit of normal (ULN) or bilirubin ≥2xULN; serum amylase or lipase levels ≥2xULN; neutrophil counts <1000 cells/μL.
MS relapse, which was classed as a MS adverse event in the safety data set.
MedDRA preferred term: Alopecia.
More than 1 serious TEAE (crude incidence) reported in either treatment group.