Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1 |
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (>= Grade 1) have been reported in this outcome measure. |
Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14 |
|
Primary |
Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2 |
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (>= Grade 1) have been reported in this outcome measure. |
Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14 |
|
Secondary |
Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 1 |
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. |
Day 3 (48 hours post-dose after the patch removal for Regimen 1) |
|
Secondary |
Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 2 |
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. |
Day 3 (48 hours post-dose after the patch removal for Regimen 2) |
|
Secondary |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
TEAEs were defined as adverse events (AEs) with an onset during or following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that did not necessarily have a causal relationship with the study drug. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. Adverse Events were only monitored/assessed on the whole participant level irrespective of different treatment regimen. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. |
Baseline up to Day 14 |
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