Adverse Reactions in Analyzable Group (n = 18) | |||||||||||
ID | Reg Date | Day | AR Description | AR# | Start Date | Stop Date | On- going | Grade | Action | Outcome | Relation |
1 | 26-Nov-14 | 85 | Fell—skinned knee | 1 | 19-Feb-15 | 19-Feb-15 | mild | no change | resolved | unrelated | |
1 | 88 | Fell—sore hip | 2 | 22-Feb-15 | 22-Feb-15 | mild | no change | resolved | unrelated | ||
2 | 26-Nov-14 | 24 | Infection—respiratory | 1 | 20-Dec-14 | 17-Jan-15 | moderate | no change | resolved | unrelated | |
2 | 28 | Diarrhea | 2 | 24-Dec-14 | 27-Dec-14 | mild | no change | resolved | unrelated | ||
2 | 68 | Decreased appetite | 3 | 02-Feb-15 | Yes | moderate | no change | chronic | doubtful | ||
3 | 06-Jan-15 | 40 | Infection—respiratory | 1 | 15-Feb-15 | 01-Mar-15 | moderate | no change | resolved | unrelated | |
8 | 09-Feb-15 | 86 | Insect bite | 1 | 06-May-15 | Yes | mild | no change | chronic | unrelated | |
10 | 09-Mar-15 | 50 | Phlegm | 1 | 28-Apr-15 | Yes | mild | no change | chronic | unrelated | |
14 | 27-Mar-15 | 61 | Hand Injury | 1 | 27-May-15 | 23-Jun-15 | moderate | no change | resolved | unrelated | |
14 | 61 | Diarrhea | 2 | 27-May-15 | 01-Jul-15 | mild | no change | chronic | unrelated | ||
16 | 13-Apr-15 | 16 | Hypertension—unstable | 1 | 29-Apr-15 | Yes | moderate | no change | chronic | unrelated | |
21 | 20-Jul-15 | 7 | Constipation | 1 | 27-Jul-15 | 03-Aug-15 | mild | no change | resolved | unrelated | |
Adverse Reactions in 3 Patients Who Took Study Drug and Then Withdrew | |||||||||||
ID | RegDate | Day | AR Description | AR# | Start Date | Stop Date | On- going | Grade | Action | Outcome | Relation |
5 | 08-Jan-15 | 0 | Lightheaded | 1 | 08-Jan-15 | 13-Jan-15 | mild | Perm Disc | resolved | probable | |
19 | 01-Jun-15 | 3 | Diarrhea | 1 | 04-Jun-15 | 22-Jun-15 | mild | Perm Disc | resolved | probable | |
20 | 02-Jul-15 | 30 | Diarrhea | 1 | 01-Aug-15 | 09-Aug-15 | severe | no change | resolved | possible | |
20 | 30 | Pain—Back | 2 | 01-Aug-15 | Yes | moderate | no change | chronic | unrelated | ||
20 | 50 | Diarrhea | 3 | 21-Aug-15 | 30-Aug-15 | severe | Perm Disc | resolved | probable |