Created at Source Raw Value Validated value
Sept. 18, 2021, 5 a.m. usa

The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection;The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection;The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs);The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) occurring up to 28 days after IMP injection in each treatment group

The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection;The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection;The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs);The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) occurring up to 28 days after IMP injection in each treatment group

July 8, 2021, 4 a.m. usa

The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection;The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection;The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs);The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) or at least one adverse event (AE) related to IMP occurring up to 28 days after IMP injection in each treatment group

The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection;The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection;The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs);The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) or at least one adverse event (AE) related to IMP occurring up to 28 days after IMP injection in each treatment group