Table 2.
Summary of AEs by SOC and PT – CORBEVAX™ and COVISHIELDTM vaccinated cohort.
| SOC/PT | CORBEVAX™ (N = 1819) |
COVISHIELD™ (N = 320) |
||||
|---|---|---|---|---|---|---|
| N (1%) n | Severity | Causality | N (1%) n | Severity | Causality | |
| OVERALL | 621 (34.1) 1313 | 136 (42·5%) (192) | ||||
| Gastrointestinal disorders | 82 (4.51%) 102 | 3 (0·94%) (4) | ||||
| Nausea | 43 (2·36%) 45 | Mild | Related (30) | 3 (0·94%) (4) | Mild | Related |
| Unrelated (15) | ||||||
| Abdominal pain upper | 21 (1·15%) 22 | Mild | Related (2) | |||
| Unrelated (20) | ||||||
| Vomiting | 18 (0.99%) 18 | Mild | Unrelated | |||
| Diarrhoea | 10 (0.55%) 10 | Mild | Unrelated | |||
| Mouth ulceration | 6 (0.33%) 6 | Mild | Unrelated | |||
| Toothache | 1 (0.05%) 1 | Mild | Unrelated | |||
| General disorders and administrative site conditions | 516 (28.37%) 828 | 107 (33·44%) (137) | ||||
| Asthenia | 5 (0.27%) 5 | Mild | Related (1) | 1 (0·31%) (1) | Mild | Related |
| Unrelated (4) | ||||||
| Chills | 15 (0.82%) 15 | Mild | Related (14) | 5 (1·56%) (5) | Mild | Related |
| Unrelated (1) | ||||||
| Fatigue | 110 (6.05%) 113 | Mild (109) | Related (108) | 8 (2·5%) (8) | Mild | Related |
| Moderate (4) | Unrelated (5) | |||||
| Injection site pain | 300 (16.49%) 319 | Mild | Related | 48 (15%) (50) | Mild | Related |
| Injection site pruritus | 52 (2.86%) 55 | Mild | Related | 6 (1·88%) (6) | Mild | Related |
| Injection site swelling | 24 (1.32%) 24 | Mild | Related | 5 (1·56%) (5) | Mild | Related |
| Injection site warmth | 3 (0.16%) 3 | Mild | Related | |||
| Irritability | 1 (0.05%) 1 | Mild | Related | 1 (0·31%) (1) | Mild | Related |
| Injection site irritation | 1 (0.05%) 1 | Mild | Related | |||
| Pyrexia | 200 (11.00%) 210 | Mild (205) | Related (187) | 50 (15·63%) (52) | Mild (51) | Related (45) |
| Moderate (5) | Unrelated (23) | Moderate (1) | Unrelated (7) | |||
| Injection site erythema | 63 (3.46%) 65 | Mild | Related | 8 (2·5%) (8) | Mild | Related |
| Pain (Generalized body pain) | 10 (0.55%) 10 | - | Related (2) | 1 (0·31%) (1) | Mild | Unrelated |
| Unrelated (8) | ||||||
| Injection site rash | 7 (0.38%) 7 | Mild | Related | |||
| Immune system disorders | 7 (0.38%) 7 | 1 (0·31%) (1) | ||||
| Urticaria | 7 (0.38%) 7 | Mild | Related | |||
| Dermatitis contact | 0 (0·0%) 0 | - | - | 1 (0·31%) (1) | Mild | Unrelated |
| Infections and infestation | 5 (0.27%) 5 | 1 (0·31%) (1) | ||||
| Dengue fever | 1 (0.05%) 1 | Severe | Unrelated | |||
| Nasopharyngitis | 4 (0.22%) 4 | Mild | Unrelated | |||
| Upper respiratory tract infection | 0 (0·0%) 0 | - | - | 1 (0·31%) (1) | Mild | Unrelated |
| Injury, poisoning and procedural complications |
1 (0·3%) (4) | 0 (0·0%) (0) | ||||
| Femur fracture | 1 (0.05%) 1 | Severe | Unrelated | 0 (0·0%) (0) | ||
| Traumatic hematoma | 1 (0.05%) 1 | Moderate | Unrelated | 0 (0·0%) (0) | ||
| Skin abrasion (Road traffic accident) |
1 (0·05%) 2 | Mild | Unrelated | 0 (0·0%) (0) | - | - |
| Musculoskeletal and connective tissue disorders | 166 (9.13%) 170 | 18 (5·63%) (24) | ||||
| Arthralgia | 4 (0.22%) 4 | Mild | Related (2) | 4 (1·25%)(6) | Mild | Related |
| Unrelated (2) | ||||||
| Back pain | 2 (0.11%) 2 | Mild (1) | Related (1) | 1 (0·31%) (1) | Mild | Unrelated |
| Moderate (1) | Unrelated (1) | |||||
| Myalgia | 162 (8.91%) 164 | Mild (159) | Related (160) | 16 (5·0%) (17) | Mild | Related |
| Moderate (5) | Unrelated (4) | |||||
| Nervous system disorders | 135 (7.42%) 143 | 21 (6·56%) (23) | ||||
| Headache | 129 (7.09%) 134 | Mild (133) | Related (104) | 21 (6·56%) (21) | Mild (20) | Related (13) |
| Moderate (1) | Unrelated (30) | Moderate (1) | Unrelated (8) | |||
| Loss of consciousness | 1 (0.05%) 2 | Moderate | Unrelated | 0 (0·0%) (0) | - | - |
| Somnolence | 4 (0.22%) 4 | Mild | Related | 1 (0·31%) (2) | Mild | Related |
| Syncope | 1 (0.05%) 2 | Moderate | Unrelated | 0 (0·0%) (0) | - | - |
| Seizure | 1 (0.05%) 1 | Moderate | Unrelated | |||
| Skin and subcutaneous tissue disorder | 8 (0.44%) 14 | 2 (0·63%) (2) | ||||
| Pruritus | 6 (0.33%) 6 | Mild (4) | Related | 0 (0·0%) (0) | - | |
| Moderate (2) | ||||||
| Rash | 7 (0.38%) 7 | Mild (3) | Related | 2 (0·63%) (2) | Mild (1) | |
| Moderate (4) | Moderate (1) | Related | ||||
| Acne | 1 (0.05%) 1 | Mild | Related | |||
| Respiratory, thoracic and mediastinal disorders | 36 (1.98%) 40 | |||||
| Cough | 24 (1.32%) 24 | Mild | Related (1) | 0 (0·0%) (0) | ||
| Unrelated (23) | - | - | ||||
| Nasal obstruction | 3 (0.16%) 3 | Mild | Related (1) | 0 (0·0%) (0) | - | - |
| Oropharyngeal pain | 6 (0.33%) 6 | Unrelated (2) Unrelated |
||||
| Mild | ||||||
| Rhinorrhoea | 3 (0.16%) 3 | Mild | Related | 0 (0·0%) (0) | - | - |
| Sneezing | 2 (0.11%) 2 | Mild | Related (1) Unrelated (1) |
0 (0·0%) (0) | - | - |
| Throat irritation | 2 (0.11%) 2 | Mild | Unrelated | 0 (0·0%) (0) | - | - |
Percentages were calculated using column header count as denominator.
95% CI was calculated by Clopper-Pearson Method.
N1: Subject Count, N: Sample Size, n: Event Count, NE: Not Estimable.
General Note.
• All AE’s were represented as: Subject count (Percentage of subjects) [95% CI] Event Count.
• Solicited Local and Systemic AEs were recorded during 7 days (day-0–6) after each dose.
• Unsolicited adverse event reported at any time, until 28 days after the each dose.