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Table 2 Patient diary, general symptoms

From: iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy

 Grade 1:
Grade 2:
Grade 3:
Grade 4:
Chills/rigorsMild hot/cold flushes requiring blanket or occasional painkillers/antipyreticsLimiting daily activity > 6 h or need regular painkillers/antipyreticsUncontrollable shaking, treatment from doctor neededHospitalization
Malaise/tirednessNormal activity reduced – not bad enough to go to bedFatigue such that 0.5 days in bed for 1 or 2 daysFatigue such that is in bed all day or 0.5 day for more than 2 daysHospitalization
General muscle achesNo limitation of activityMuscle tenderness, limited activity, e.g., difficulty climbing stairsSevere limitation, e.g., cannot climb stairsHospitalization
HeadacheNo treatment or responds to usual treatment like paracetamolOccasional treatment like paracetamol neededStrong pain killers needed (with prescription)Hospitalization
NauseaIntake maintainedIntake reduced at most 3 daysMinimal intake 3 days or moreHospitalization
VomitingLess than 4 × a day or lasting less than 1 weekAt least 4 x a day or lasting 1 week or moreUnable to keep any food of fluids downHospitalization
  1. General symptoms are scored on a grade 1–4 scale at 12 h and 24 h post immunization. This is repeated every 24 h up to and including day 7